Remote controller for substance delivery system

ABSTRACT

Embodiments of a system including a remotely controlled substance delivery device and associated controller are described. Methods of use and control of the device are also disclosed. According to some embodiments, a delivery device or related device may be placed in an environment in order to pump a material into the environment or into an additional fluid handling structure within the device. Exemplary environments include a body of an organism, a body of water, or an enclosed volume of a fluid. The concentration of a substance in the fluid to be delivered may be modified by a remote control signal. In selected embodiments, a magnetic field, an electric field, or electromagnetic control signal may be used.

CROSS-REFERENCE TO RELATED APPLICATIONS

For purposes of the United States Patent Office (USPTO) extra-statutoryrequirements, the present application is a DIVISION application of U.S.patent application Ser. No. 11/335,911 titled REMOTE CONTROLLER FORSUBSTANCE DELIVERY SYSTEM, naming LEROY E. HOOD, MURIEL Y. ISHIKAWA,EDWARD K. Y. JUNG, ROBERT LANGER, CLARENCE T. TEGREENE, LOWELL L. WOOD,JR. AND VICTORIA Y. H. WOOD as inventors, filed 18 Jan. 2006, which isco-pending, or is an application of which a co-pending application isentitled to the benefit of the filing date. The present applicationclaims the benefit of the earliest available effective filing date(s)(i.e., claims earliest available priority dates for other thanprovisional patent applications or claims benefits under 35 USC §119(e)for provisional patent applications) for any and all applications towhich patent application Ser. No. 11/335,911 claims the benefit ofpriority, including but not limited to U.S. patent application Ser. No.11/270,799, titled REMOTE CONTROLLED IN SITU REACTION METHOD naming asinventors LEROY E. HOOD, MURIEL Y. ISHIKAWA, EDWARD K. Y. JUNG, ROBERTLANGER, CLARENCE T. TEGREENE, LOWELL L. WOOD, JR., AND VICTORIA Y. H.WOOD, filed 9 Nov. 2005 and U.S. patent application Ser. No. 11/271,145,titled REACTION DEVICE CONTROLLED BY MAGNETIC CONTROL SIGNAL naming asinventors LEROY E. HOOD, MURIEL Y. ISHIKAWA, EDWARD K. Y. JUNG, ROBERTLANGER, CLARENCE T. TEGREENE, LOWELL L. WOOD, JR., AND VICTORIA Y. H.WOOD, filed 9 Nov. 2005. All subject matter of U.S. patent applicationSer. No. 11/270,799, and of any and all applications from which itclaims the benefit of the earliest available effective filing date(s)and U.S. patent application Ser. No. 11/271,145, and of any and allapplications from which it claims the benefit of the earliest availableeffective filing date(s) is incorporated herein by reference to theextent such subject matter is not inconsistent herewith. The applicantentity has provided above a specific reference to the application(s)from which priority is being claimed—as required by statute. Applicantentity understands that the statute is unambiguous in its specificreference language and does not require either a serial number or anycharacterization, such as “continuation” or “continuation-in-part” or“divisional,” for claiming priority to U.S. patent applications.Notwithstanding the foregoing, the applicant entity has provided above aspecific reference to the application(s) from which priority is beingclaimed, but expressly points out that such designations are not to beconstrued in any way as any type of commentary and/or admission as towhether or not the present application contains any new matter inaddition to the matter of its parent application(s). Further, anydesignation that the present application is a “division” should not beconstrued as an admission that the present application claims subjectmatter that is patentably distinct from claimed subject matter of itsparent application.

BACKGROUND

Implantable controlled release devices for drug delivery have beendeveloped. Certain devices rely upon the gradual release of a drug froma polymeric carrier over time, due to degradation of the carrier.Polymer-based drug release devices are being developed that include adrug in a ferropolymer that may be heated by an externally appliedmagnetic field, thus influencing the drug release. MEMS based drugrelease devices that include integrated electrical circuitry are alsounder development, as are MEMS based systems for performing chemicalreactions. Implantable delivery devices have been developed for drugdelivery purposes. Wireless transmission of electromagnetic signals ofvarious frequencies is well known in the areas of communications anddata transmission, as well as in selected biomedical applications.

SUMMARY

The present application relates, in general, to the field of fluiddelivery devices, systems, and methods. In particular, the presentapplication relates to remotely controlled delivery devices in which theconcentration of a material in a fluid to be delivered may be varied.Control signals may be carried between a remote controller and adelivery device in an environment by electrical, magnetic, orelectromagnetic fields or radiation. Embodiments of a system including aremotely controlled delivery device and associated controller aredescribed. Methods of use and control of the device are also disclosed.According to various embodiments, a delivery device may be placed in anenvironment in order to eject or release a material into theenvironment. Exemplary environments include a body of an organism, abody of water or other fluid, or an enclosed volume of a fluid.According to some embodiments, a delivery device may provide fordelivery of a fluid into a downstream fluid-handling structure. Theforegoing summary is illustrative only and is not intended to be in anyway limiting. In addition to the illustrative aspects, embodiments, andfeatures described above, further aspects, embodiments, and featureswill become apparent by reference to the drawings and the followingdetailed description.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 depicts an embodiment of a delivery system for use in a humansubject;

FIG. 2 depicts an embodiment of a delivery system including a remotecontroller;

FIG. 3 depicts another embodiment of a delivery system including aremote controller;

FIGS. 4A and 4B illustrate in schematic form a change in concentrationin a fluid to be delivered by an embodiment of a delivery device;

FIG. 5 depicts an electromagnetically responsive control elementincluding a polymer and magnetically or electrically active components;

FIG. 6A-6D show examples of first active and second forms of primarymaterial in delivery fluid;

FIGS. 7A and 7B illustrate a change in concentration in delivery fluidin exemplary delivery device including an osmotic pump;

FIGS. 8A and 8B illustrate a change in concentration in a delivery fluidproduced by a heating element;

FIGS. 9A and 9B illustrate a change in concentration in a delivery fluidproduced by a cooling element;

FIGS. 10A and 10B illustrate a change in concentration in a deliveryfluid produced by interaction of a primary material with an interactionregion;

FIGS. 11A and 11B illustrate a change in concentration of primarymaterial influenced by secondary material in a delivery fluid;

FIG. 12A depicts an exemplary interaction region;

FIG. 12B depicts expansion of the interaction region of FIG. 12A in afirst direction;

FIG. 12C depicts expansion of the interaction region of FIG. 12A in asecond direction;

FIG. 12D depicts expansion of the interaction region of FIG. 12A infirst and second directions;

FIGS. 13A and 13B depict unfolding of a pleated interaction region;

FIGS. 14A and 14B depict another embodiment of an interaction region;

FIGS. 15A and 15B depict an example of an effect of stretching aninteraction region;

FIGS. 16A and 16B depict another example of an effect of stretching aninteraction region;

FIGS. 17A and 17B depict an exemplary embodiment of an interactionregion;

FIGS. 18A and 18B depict another exemplary embodiment of an interactionregion;

FIGS. 19A and 19B depict another exemplary embodiment of an interactionregion;

FIGS. 20A and 20B illustrate expansion of a delivery reservoir of adelivery device;

FIG. 21 is a schematic diagram of an embodiment of a delivery device;

FIG. 22 is a schematic diagram of another embodiment of a deliverydevice;

FIG. 23 depicts an embodiment of a system including a remotelycontrolled delivery device;

FIG. 24 depicts another embodiment of a system including a remotelycontrolled delivery device;

FIG. 25 depicts another embodiment of a system including a remotelycontrolled delivery device;

FIG. 26 illustrates a control signal generated from stored pattern data;

FIG. 27 illustrates a control signal calculated from a model based onstored parameters;

FIG. 28 is a schematic diagram of a remote controller;

FIG. 29 depicts an exemplary control signal;

FIG. 30 depicts another exemplary control signal;

FIG. 31 depicts another exemplary control signal;

FIG. 32 illustrates an embodiment of a delivery device including adownstream fluid handling structure;

FIG. 33 illustrates another embodiment of a delivery device including adownstream fluid handling structure;

FIG. 34 illustrates an embodiment of a delivery device including a fluidcontaining structure;

FIG. 35 illustrates an embodiment of a delivery device including anenvironmental interface;

FIG. 36 is a flow diagram of a method of delivering a fluid;

FIG. 37 is a flow diagram of a further method of delivering a fluid;

FIG. 38 is a flow diagram of a further method of delivery a fluid;

FIG. 39 is a schematic diagram of an embodiment of a system including aremote controller and a delivery device;

FIG. 40 is a diagram of an embodiment of a delivery system including adelivery device with an RFID;

FIG. 41 is a schematic diagram of an embodiment a system including aremote controller, a delivery device, and a sensor;

FIG. 42 is a schematic diagram of an embodiment a system including aremote controller and a delivery device including a sensor;

FIG. 43 is a schematic diagram of another embodiment of system includinga remote controller and a delivery device; and

FIG. 44 is an embodiment of a system including a remote controller and aplurality of delivery devices in an environment.

FIG. 45 is a schematic of an embodiment of a delivery system;

FIG. 46 is a schematic of a further embodiment of a delivery system;

FIG. 47 is a schematic of a further embodiment of a delivery system;

FIG. 48 is a schematic of another embodiment of a delivery system;

FIG. 49 depicts an embodiment of a delivery system including encryption;

FIG. 50 depicts a embodiment of a delivery system that utilizes anauthentication procedure;

FIG. 51 is a flow diagram of a method of delivering a fluid;

FIG. 52 is a flow diagram of a method of delivering a material;

FIG. 53 is a flow diagram of a portion of a method of delivering amaterial;

FIG. 54 is a flow diagram of another method of delivering a material;

FIG. 55 is a flow diagram of an expansion of the method of FIG. 54;

FIG. 56 is a flow diagram of an expansion of the method of FIG. 54;

FIG. 57 is a flow diagram of a further method of delivering a material;

FIG. 58 is a flow diagram of a method of controlling a delivery device;

FIG. 59 is an expansion of the method of FIG. 58;

FIG. 60 is a flow diagram of additional steps for controlling a deliverydevice;

FIG. 61 is a flow diagram of alternative additional steps forcontrolling a delivery device;

FIG. 62 is a flow diagram of further alternative additional steps forcontrolling a delivery device;

FIG. 63 is a further expansion of the method of FIG. 58;

FIG. 64 is another expansion of the method of FIG. 58; and

FIG. 65 is still another expansion of the method of FIG. 58;

DETAILED DESCRIPTION

In the following detailed description, reference is made to theaccompanying drawings, which form a part hereof. In the drawings,similar symbols typically identify similar components, unless contextdictates otherwise. The illustrated embodiments described in thedetailed description, drawings, and claims are not meant to be limiting.Other embodiments may be utilized, and other changes may be made,without departing from the spirit or scope of the subject matterpresented here.

FIG. 1 depicts a first exemplary embodiment of a delivery system 10. Inthe embodiment of FIG. 1, delivery system 10 includes delivery device 12located in an environment 14, (which in this particular example is ahuman body) and remote controller 16. As used herein, the term “remote”refers to the transmission of information (e.g. data or control signals)or power signals or other interactions between spatially separateddevices or apparatuses, such as the remote controller or the deliverysystem, without a connecting element such as a wire or cable linking theremote controller and the delivery system, and does not imply aparticular spatial relationship between the remote controller and thedelivery device, which may, in various embodiments, be separated byrelatively large distances (e.g. miles or kilometers) or a relativelysmall distances (e.g. inches or millimeters). Delivery device 12includes an electromagnetically responsive control element 18 that isresponsive to an electromagnetic control signal generated by remotecontroller 16.

FIG. 2 depicts an embodiment of a delivery system 20 including adelivery device 22 controlled by remote controller 24. In the embodimentof FIG. 2, delivery device 22 includes pump 26 and delivery reservoir 28which contains delivery fluid 30. Remote controller 24 transmitselectromagnetic control signal 32 to electromagnetically responsivecontrol element 34 to control the concentration of primary material 36in delivery fluid 30. Pump 26 pumps delivery fluid 30 containing primarymaterial 36 from delivery reservoir 28 via outlet 37. Delivery device 22also includes a body structure 38.

FIG. 3 depicts another embodiment of a delivery system 40 including adelivery device 42 controlled by remote controller 44. In the embodimentof FIG. 3, delivery device 42 includes pump 46 and delivery reservoir28, which contains delivery fluid 30. Remote controller 44 transmitselectromagnetic distribution control signal 32 to electromagneticallyresponsive control element 34 to control the concentration of primarymaterial 36 in delivery fluid 30. Remote controller 44 also transmitselectromagnetic delivery control signal 48 to receiving element 50 inpump 46 to control the pumping of delivery fluid 30 from deliveryreservoir 28. Outlet 37 and body structure 38 are also included indelivery device 48.

FIGS. 4A and 4BA illustrate in schematic form a delivery device 60comprising a delivery reservoir 62 configured to contain a deliveryfluid, the delivery reservoir having at least one outlet 64 throughwhich the delivery fluid may exit the delivery reservoir; a deliveryfluid 66 contained within the delivery reservoir 62; a primary material68 contained within the delivery reservoir 62 and having a controllableeffective concentration in the delivery fluid; and at least oneelectromagnetically responsive control element 70 adapted for modifyingthe distribution of the primary material between a first active formcarried in the delivery fluid and a second form in response to anincident electromagnetic control signal, the effective concentrationbeing the concentration of the first active form in the delivery fluid.Delivery fluid may exit delivery reservoir 66 by diffusion, or by beingmoved out of delivery reservoir 66 by positive pressure applied todelivery reservoir 62 (e.g. by a pump) or negative pressure generateddownstream of delivery reservoir 62. FIG. 4A illustrates a first stateof electromagnetically responsive control element 70, which causesprimary material 68 to be in a first active form in delivery fluid 66.FIG. 4B illustrates a second state of electromagnetic control element70, which causes the primary material to be in a second form 68′, whichis not an active form carried in delivery fluid 66, but may be, forexample, insoluble in delivery fluid 66 as depicted in FIG. 4B.

In order to modify the distribution of primary material between thefirst active form and the second form, the electromagneticallyresponsive control element used in this and other embodiments (e.g., 34in FIGS. 2 and 3 or 70 in FIGS. 4A and 4B) may have various functionalcharacteristics. In some embodiments, the electromagnetically responsivecontrol element may include or form a heating element (e.g., a resistiveelement) or a cooling element (which may be, for example, athermoelectric device). In some embodiments, the electromagneticallyresponsive control element may be an expanding element. In someembodiments, an electromagnetically responsive control element mayinclude a receiving element such as an antenna or other geometric gainstructure to enhance the receiving of an electromagnetic control signaltransmitted from a remote control signal generator. The response of theelectromagnetically responsive control element to an electromagneticfield may be due to absorption of energy from the electromagnetic signalor due to torque or traction on all or a portion of theelectromagnetically responsive control element due to theelectromagnetic field. The response will depend upon the intensity, therelative orientation and the frequency of the electromagnetic field andupon the geometry, composition and preparation of the material of theelectromagnetically responsive control element. A response may occur onthe macro level, on a microscopic level, or on a nanoscopic or molecularlevel. In some embodiments, the electromagnetically responsive controlelement may respond to the control signal by changing shape. In someembodiments, the electromagnetically responsive control element mayrespond to the control signal by changing in at least one dimension. Theresponse of the electromagnetically responsive control element mayinclude one or more of heating, cooling, vibrating, expanding,stretching, unfolding, contracting, deforming, softening, or foldingglobally or locally. In some embodiments, the electromagneticallyresponsive control element may be configured to selectively respond toan electromagnetic field having a specific frequency and orientation.Frequency selectivity may be conferred by appropriate selection ofelectromagnetically responsive control element size relative to thewavelength of the electromagnetic signal, while directional selectivitymay be conferred by the configuration and orientation of theelectromagnetically responsive control element.

Electromagnetically responsive control elements used in variousembodiments of delivery devices and systems may include one or moreelectromagnetically active materials. The electromagnetically responsivecontrol element may include a magnetically or electrically activematerial. Examples of magnetically active materials include permanentlymagnetizable materials, ferromagnetic materials such as iron, nickel,cobalt, and alloys thereof, ferrimagnetic materials such as magnetite,ferrous materials, ferric materials, diamagnetic materials such asquartz, paramagnetic materials such as silicate or sulfide, andantiferromagnetic materials such as canted antiferromagnetic materialswhich behave similarly to ferromagnetic materials; examples ofelectrically active materials include ferroelectrics, piezoelectrics,dielectric materials, including permanently ‘poled’ dielectrics anddielectrics having both positive and negative real permittivities, andmetallic materials.

In some embodiments, the electromagnetically responsive control elementmay include a hydrogel, ferrogel, or ferroelectric. Theelectromagnetically responsive control element may include a polymer,ceramic, dielectric, or metal. The electromagnetically responsivecontrol element may include various materials, such as polymers,ceramics, plastics, dielectrics or metals, or combinations thereof. Insome embodiments, the electromagnetically responsive control element mayinclude a polymer and a magnetically or electrically active component.In some embodiments, the electromagnetically responsive control elementmay include a shape memory material such as a shape memory polymer or ashape memory metal, or a composite structure such as a bimetallicstructure.

In some embodiments, the electromagnetically responsive control elementmay include a polymer and an electrically active component (includinghighly polarizable dielectrics) or a magnetically active component(including ferropolymers and the like). In embodiments in which theelectromagnetically responsive control element includes one or moreelectrically or magnetically active components, the electrically ormagnetically active component may respond to an electromagnetic controlsignal in a first manner (e.g., by heating) and the response of theelectromagnetically responsive control element may be produced inresponse to the electrically or magnetically active component (e.g.expansion or change in shape in response to heating of the electricallyor magnetically active component). Electromagnetically responsivecontrol elements may, in some embodiments, be composite structures.

FIG. 5 depicts an example of an electromagnetically responsive controlelement 100 including a composite structure formed from a polymer 102and multiple electrically or magnetically active components in the formof multiple particles 104 distributed through polymer 102. In someembodiments, the electrically or magnetically active components may beheatable by the electromagnetic control signal, and heating of theelectrically or magnetically active components may cause the polymer toundergo a change in configuration. An example of a magneticallyresponsive polymer is described, for example, in Neto, et al, “Optical,Magnetic and Dielectric Properties of Non-Liquid Crystalline ElastomersDoped with Magnetic Colloids”; Brazilian Journal of Physics; bearing adate of March 2005; pp. 184-189; Volume 35, Number 1, which isincorporated herein by reference. Other exemplary materials andstructures are described in Agarwal et al., “Magnetically-driventemperature-controlled microfluidic actuators”; pp. 1-5; or U.S. Pat.No. 6,607,553, both of which are incorporated herein by reference.

As mentioned in connection with FIGS. 2-4B, the delivery device maycontain a primary material (the material that is intended to bedelivered to an environment or other downstream location) in a deliveryfluid. The primary material may be distributed between a first activeform (in which it is usable or active) and a second form in which it isinactive, inaccessible, or otherwise unavailable or unusable). The firstactive form of the primary material may be carried in solution, insuspension, in emulsion, or in colloidal suspension in the deliveryfluid, so that it may be delivered from the delivery device along withthe delivery fluid. In some embodiments, the second form may be aninactive form of the primary material, which may be carried in thedelivery fluid along with the first active form. The second form may becarried in the delivery fluid in solution, in suspension, in emulsion,or in colloidal dispersion, for example.

In some such embodiments, the second form may be a chemically inactiveform. This case is depicted in FIG. 6A, in which the first active formis indicated by reference number 150, and the second (chemicallyinactive) form is indicated by reference number 152. Delivery reservoir154, including outlet 156 and electromagnetically responsive controlelement 158 are also indicated. Both first active form 150 and secondform 152 are carried in delivery fluid 153.

In other embodiments, as illustrated in FIG. 6B, the second form 160 mayinclude a chemically active form of the primary material 162 containedin a carrier structure 164, while the first active form 166 is notcontained in a carrier structure. The carrier structure may be, forexample, a capsule, microcapsule, micelle, or fullerene, or othercarrier structure known to those of skill in the relevant art. Deliveryreservoir 154 includes outlet 156 and electromagnetically responsivecontrol element 168.

In still other embodiments, as illustrated in FIG. 6C, the second form176 may be bound or associated with an interaction region 178 in thedelivery reservoir 154, while the first active form 150 is carried indelivery fluid 153. Interaction of second form 176 with interactionregion 178 may be controlled by electromagnetically responsive controlelement 180.

As shown in FIG. 6D, in some embodiments, the second form 186 may beinsoluble in the delivery fluid 153; for example, the second form 186may be precipitated out of the delivery fluid while first active form188 is carried in delivery fluid 153. As illustrated in FIG. 6D, thedelivery reservoir 154 may include filter 190 located between thedelivery reservoir 154 and the outlet 156 and configured for removingthe second form 186 from the delivery fluid 153. For example, openings192 in filter 190 may be large enough to allow first form 188 to passthrough, but too small to allow precipitated second form 186 to passthrough the filter. In other embodiments, the filter may operate basedupon increased affinity for the second form over the first active form,or other filtering principle, as is well known in the field offiltration. The term ‘filter’ is intended to encompass various types ofmaterials-separating device.

The primary material may have a different immunogenicity, reactivity,stability, or activity when it is in the first active form than when itis in the second form. The primary material may be any of a wide varietyof materials, including single materials or mixtures of materials. Forexample, the primary material may be a pharmaceutical material or aneutraceutical material. The primary material may be a biologicallyactive material. In some embodiments, the primary material may includeat least one nutrient, hormone, growth factor, medication, therapeuticcompound, enzyme, genetic material, vaccine, vitamin, neurotransmitter,cytokine, cell-signaling material, pro- or anti-apoptotic agent, imagingagent, labeling agent, diagnostic compound, nanomaterial, inhibitor, orblocker. In some embodiments, the primary material may be a component orprecursor of a biologically active material; for example, the primarymaterial may include at least one precursor or component of a nutrient,hormone, growth factor, medication, therapeutic compound, enzyme,genetic material, vaccine, vitamin, neurotransmitter, cytokine,cell-signaling material, pro- or anti-apoptotic agent, imaging agent,labeling agent, diagnostic compound, nanomaterial, inhibitor, orblocker. Such precursors, may include, for example, prodrugs (see, e.g.,“Liver-Targeted Drug Delivery Using HepDirect1 Prodrugs,” Erion et al.,Journal of Pharmacology and Experimental Therapeutics Fast Forward, JPET312:554-560, 2005 (first pub Aug. 31, 2004) and “LEAPT: Lectin-directedenzyme-activated prodrug therapy”, Robinson et al., PNAS Oct. 5, 2004vol. 101, No. 40, 14527-14532, published online before print Sep. 24,2004, both of which are incorporated herein by reference. Beneficialmaterials may be produced, for example, by conversion of pro-drug todrug, enzymatic reaction of material in bloodstream (CYP450, cholesterolmetabolism, e.g., with cholesterol monooxygenase, cholesterol reductase,cholesterol oxidase). Depending on the intended application or useenvironment for the delivery device, the primary material may include atleast one fertilizer, nutrient, remediation agent, antibiotic,microbicide, herbicide, fungicide, transfection agent, nanomaterial,disinfectant, metal salt, a material for adjusting a chemicalcomposition or pH, such as buffer, acid, base, chelating agent,emulsifying agent, or surfactant. In some embodiments, the primarymaterial may include a tissue-specific marker or targeting molecule,which may be, for example, a tissue-specific endothelial protein. Atissue-specific marker or targeting molecule may assist in targeting ofthe primary material to a specific location or tissue within a body ofan organism.

The term “delivery fluid” as used herein, is intended to cover materialshaving any form that exhibits fluid or fluid-like behavior, includingliquids, gases, powders or other solid particles in a liquid or gascarrier. The delivery fluid may be a solution, suspension, or emulsion.

Typically, the effective concentration of the primary material will bethe concentration of the first active form of the primary material inthe delivery fluid, which may differ from the total concentration ofprimary material in the delivery fluid, which is the combinedconcentration of both the first active and second forms of the primarymaterial. The effective rate of delivery of primary material from thedelivery device will generally equal the rate at which delivery fluid ispumped (or otherwise moves or is moved) out of the delivery reservoirmultiplied by the effective concentration of primary material in thedelivery fluid. A delivery device may include a pump for pumpingdelivery fluid from the delivery reservoir. Alternatively, in some casesthe primary material may simply diffuse out of the delivery device.Various types of pumps may be used, without limitation. Suitable pumpsmay include, for example, osmotic, mechanical, displacement,centrifugal, and peristaltic pumps.

FIGS. 7A and 7B illustrate an embodiment of a delivery device thatincludes an osmotic pump. Delivery device 250 includes deliveryreservoir 252, which contains delivery fluid 254 and may have an outlet256. Electromagnetically responsive control element 258 is located indelivery reservoir 252 to control the distribution of primary material,which in FIG. 7A is shown in the second (inactive, inaccessible orunusable) form 260. Osmotic pump 262 includes osmotic chamber 264containing osmotic pressure generating material 266. Semi-permeablemembrane 268 is permeable to osmotic fluid 270 but not to osmoticpressure generating material 266. Osmotic fluid 270 thus flows intoosmotic chamber 264. This causes movable barrier 274 (which may be arigid movable barrier or a flexible membrane) to move into deliveryreservoir 252, thus pumping delivery fluid 254 out of outlet 256. Asshown in FIG. 7B, activation of electromagnetically responsive controlelement 258 may cause primary material to be converted to first activeform 272.

Various different osmotic pressure-generating materials may be used indelivery systems as described herein. For example, the osmoticpressure-generating material may include ionic and non-ionicwater-attracting or water absorbing materials, non-volatilewater-soluble species, salts, sugars, polysaccharides, polymers,hydrogels, osmopolymers, hydrophilic polymers, and absorbent polymers,among others. Water-attracting materials may include non-volatile,water-soluble species such as magnesium sulfate, magnesium chloride,potassium sulfate, sodium chloride, sodium sulfate, lithium sulfate,sodium phosphate, potassium phosphate, d-mannitol, sorbitol, inositol,urea, magnesium succinate, tartaric acid, raffinose, variousmonosaccharides, oligosaccharides and polysaccharides, such as sucrose,glucose, lactose, fructose, dextran, and mixtures thereof. Waterabsorbing materials include osmopolymers, for example hydrophilicpolymers that swell upon contact with water. Examples of water-absorbingmaterials include poly(hydroxyl alkyl methacrylates) MW30,000-5,000,000, polyvinylpyrrolidone MW 10,000-360,000, anionic andcationic hydrogels, polyelectrolyte complexes, poly(vinyl alcohol)having low acetate residual, optionally cross linked with glyoxal,formaldehyde, or glutaraldehyde and having a degree of polymerization of200 to 30,000, mixtures of e.g., methylcellulose, cross linked agar andcarboxymethylcellulose; or hydroxypropyl methycellulose and sodiumcarboxymethylcellulose; polymers of N-vinyllactams, polyoxyethylenepolyoxypropylene gels, polyoxybutylene-polyoxethylene block copolymergels, carob gum, polyacrylic gels, polyester gels, polyuria gels,polyether gels, polyamide gels, polypeptide gels, polyamino acid gels,polycellulosic gels, carbopol acidic carboxy polymers MW250,000-4,000,000, cyanamer polyacrylamides, cross-linked indene-maleicanhydride polymers, starch graft copolymers, acrylate polymerpolysaccharides. Other water attracting and/or water absorbing materialsinclude absorbent polymers such as poly(acrylic acid) potassium salt,poly(acrylic acid) sodium salt, poly(acrylic acid-co-acrylamide)potassium salt, poly(acrylic acid) sodium salt-graft-poly(ethyleneoxid), poly(2-hydroxethyl methacrylate) and/or poly(2-hydropropylmethacrylate) and poly(isobutylene-co-maleic acid). A variety of osmoticpressure-generating materials and/or water-absorbing materials aredescribed in US 2004/0106914 and US 2004/0015154, both of which areincorporated herein by reference in their entirety.

The osmotic pressure-generating ability of the osmoticpressure-generating material may depend on the solubility of the osmoticpressure-generating material in the osmotic fluid, and/or upon theconcentration of the osmotic pressure-generating material in the osmoticfluid, and varying either concentration or solubility may modify theosmotic-pressure generating ability of the osmotic pressure-generatingmaterial. Concentration of the osmotic pressure-generating material inthe osmotic fluid may be modifiable by a change in solubility of theosmotic pressure-generating material in response to an electromagneticfield control signal or by a change in the osmotic fluid in response toan electromagnetic field control signal.

FIGS. 8A and 8B depict an embodiment of a delivery device 300 in whichthe electromagnetically responsive control element 302 includes anelectromagnetic field responsive heating element that may respond to thecontrol signal by producing heat. Primary material 304 is containedwithin delivery reservoir 306 in delivery fluid 307. Electromagneticallyresponsive control element 302 may be located in the wall of deliveryreservoir 306. Electromagnetically responsive control element 302 has aninitial temperature T₁. Following heating of electromagneticallyresponsive control element 302 in response to an electromagnetic controlsignal, electromagnetically responsive control element 302 has asubsequent temperature T₂, as shown in FIG. 8B. The change intemperature of electromagnetically responsive control element 302 maymodify the concentration of primary material 304 within deliveryreservoir 306. In FIG. 8A, portion 305 of primary material 304 isinsoluble, while in FIG. 8B, all of primary material 304 has gone intosolution, due to the change in temperature of delivery fluid 307. Theelectromagnetic field responsive control element 302 may include aferrous, ferric, or ferromagnetic material, or other material with asignificant electromagnetic “loss tangent” or resistivity. In thepresent example, the solubility of the primary material 304 in thedelivery fluid 307 is depicted as increasing with increasingtemperature, but in some embodiments, the solubility may decrease withincreasing temperature. As in previously described embodiment, deliverydevice 300 may also include pump 308 and outlet 310.

FIGS. 9A and 9B depict another embodiment of a delivery device 350, inwhich the at least one electromagnetically responsive control element352 may include an electromagnetic field responsive cooling element. Theelectromagnetic field responsive cooling element may be capable ofproducing a decrease in temperature in the delivery fluid, wherein theprimary material 354 has a solubility in the delivery fluid 356 thatchanges in response to a decrease in temperature of the delivery fluid.The electromagnetic field responsive cooling element 352 may include athermoelectric element, for example. Methods and/or mechanisms ofproducing cooling may include, but are not limited to, thermoelectric(Peltier Effect) and liquid-gas-vaporization (Joule-Thomson) devices, ordevices which employ “phase-changing” materials or systems involvingsignificant enthalpies of transition. The solubility of the primarymaterial 354 may increase with decreasing temperature, or it maydecrease with decreasing temperature, as depicted in FIGS. 9A and 9B. InFIG. 9A, for example, cooling element 352 is not producing cooling, andthe temperature is at a higher temperature T₁ and primary material 354is substantially all in solution in delivery fluid 356. In FIG. 9B,cooling element 352 may be activated to produce cooling, so that thetemperature of delivery fluid 356 decreases to temperature T₂. Attemperature T₂ a portion 358 or primary material goes out of solution,resulting in a lower effective concentration of primary material indelivery fluid 356.

In some embodiments of the delivery device, the at least oneelectromagnetically responsive control element may be a shape-changingstructure that changes in at least one dimension in response to anelectromagnetic control signal. FIGS. 10A and 10B depict delivery device400 that includes an electromagnetically responsive control element 402that is a shape-changing structure located in the wall of deliveryreservoir 404. An interaction region 406 including interaction sites 408may be located on or adjacent to electromagnetically responsive controlelement 402, so that the dimension of interaction region 406 is modifiedwith the change in dimension of electromagnetically responsive controlelement 402. Interaction sites 408 may bind primary material 410, thuskeeping it out of solution, and maintaining a lower effectiveconcentration in delivery reservoir 404; a change in spacing or exposureof interaction sites 408 may modify the interaction of primary material410 with interaction sites 408, and thus modifies the effectiveconcentration in delivery reservoir 404. For example, in FIG. 10B, theelectromagnetically responsive control element 402′ has contracted in atleast one dimension to produce a corresponding decrease in size ofinteraction region 406, and reduction in spacing between interactionsites 408. In the example depicted in FIG. 10B, the reduction ininteraction site spacing reduces interactions with primary material 410,causing it to go into solution in delivery fluid 412 in higherconcentration.

Interaction sites may be localized to an interaction region, as depictedin FIGS. 10A and 10B, or, in alternative embodiments, the interactionsites may be distributed to various locations within the deliveryreservoir. The delivery device may include a plurality of interactionsites for the primary material within the delivery reservoir, thelikelihood of interaction of the primary material with the interactionsites controllable by the electromagnetic field control signal, whereininteraction of the primary material with the interaction sites causes achange in effective concentration within the delivery reservoir. Theinteraction sites may be capable of interacting with the primarymaterial by one or more of binding, reacting, interacting, or forming acomplex with the primary material. The interaction sites may beresponsive to an electromagnetic field control signal by a change in atleast one characteristic, the change in the at least one characteristicmodifying the interaction between the interaction sites and the primarymaterial. The at least one characteristic may include, but is notlimited to, at least one of a solubility, a reactivity, a distributionwithin the delivery reservoir, a density, a temperature, a conformation,an orientation, an alignment, or chemical potential, for example.

In some embodiments, the at least one electromagnetically responsivecontrol element may be an electromagnetic field responsive molecule inthe delivery fluid, and wherein the electromagnetic field responsivemolecule undergoes a change in conformation from a first conformationstate to a second conformation state in response to the electromagneticcontrol signal, and wherein the first conformation state has a firstsolubility in the delivery fluid and wherein the second conformationstate has a second solubility in the delivery fluid. Such anelectromagnetic field responsive molecule may form at least a portion ofthe primary material in the delivery fluid, or alternatively, theelectromagnetic field responsive molecule may form at least a portion ofa secondary material that influences the solubility of the primarymaterial in the delivery fluid, as illustrated in FIGS. 11A and 11B.

FIG. 11A depicts a delivery device 420 including delivery reservoir 422and pump 424. Delivery reservoir 422 contains delivery fluid 425,primary material 426, and secondary material 428. Delivery fluid 424 mayexit delivery reservoir 422 via outlet 430. In FIG. 11A, secondarymaterial 428 is all in solution, and a portion 432 of primary materialhas been forced out of solution. In FIG. 11B, in response to a change inthe electromagnetic field control signal, a portion 434 of secondarymaterial 428 has gone out of solution, with the effect that a largeramount of primary material 426 goes into solution, thus increasing theconcentration of primary material 426 in delivery fluid 242. Secondarymaterial 428 may influence the concentration of primary material 426 bymodifying the pH, polarity or other characteristic of delivery fluid244, or by interacting or reacting with primary material 426 directly tomodify its solubility in delivery fluid 424.

FIGS. 10A and 10B depict one method of using a shape changing materialto vary the effective concentration of a primary material in a deliverydevice. Other embodiments that utilize shape-changing materials are alsocontemplated. A shape-changing structure may include a polymericmaterial, a ferropolymer, a hydrogel, a bimetallic structure, or a shapememory material. In some embodiments, the shape-changing structure maybe an expanding or contracting structure, wherein the change in at leastone dimension includes an expansion or contraction in at least onedimension. Expansion or contraction of the expanding or contractingstructure may modify the volume of a delivery reservoir, or exposemolecular structures to the delivery fluid that modify the solubility ofthe primary material in the delivery fluid, as will be discussed in thefollowing example.

A change in surface area may be produced by stretching a portion of thedelivery reservoir, as depicted in FIGS. 12A-12D, or a change in surfacearea may be produced by unfolding a portion of the delivery reservoir,as depicted in FIGS. 13A and 13B, or by some of change in conformationof at least a portion of the delivery reservoir.

FIGS. 12A-12D depict the effect of changes in one or two dimensions onan interaction region 450. Such an interaction region may be formed, forexample, on an electromagnetically responsive control element thatexpands in response to a control signal. Interaction region 450 mayinclude a plurality of reaction sites 452, and having initial length ofx₁ in a first dimension and y₁ in a second dimension. FIG. 12B depictsinteraction region 450 following a change in the first dimension, to alength x₂. FIG. 12C depicts interaction region 450 following a change inthe second dimension, to a length y₂, and FIG. 12D depicts interactionregion 450 following a change in both the first and second dimensions,to a size of x₂ by y₂. In each case, a change in dimension results in achange in distance between reaction sites 452. The dimension changedepicted in FIGS. 12A-12D may be viewed as a ‘stretching’ or ‘expansion’of the interaction region. Increasing the surface area of theinteraction region may increase the rate of the reaction. Increasing thesurface area of the interaction region (e.g., by stretching the surface)may increase the distance between reaction sites on the interactionregion. An increased distance between reaction sites may lead to anincrease in reaction rate (for example, in cases where smaller spacingbetween reaction sites leads to steric hindrance that blocks access ofreactants to reaction sites).

In addition to increasing surface areas or reaction volumes, expansionof an electromagnetically responsive control element may also have theeffect of exposing additional portions of an interaction region orexposing additional functional group to influence a reaction condition.Increasing the surface area of the interaction region by unfolding orother forms of ‘opening’ of the interaction region structure of at leasta portion of the reaction area may increase the number of reaction siteson the interaction region (e.g. by exposing additional reaction sitesthat were fully or partially hidden or obstructed when the interactionregion was in a folded configuration). For example, the area of aninteraction region may be increased by the unfolding of at least aportion of the reaction area to expose additional portions of thereaction area, as depicted in FIGS. 13A and 13B. In FIG. 13A, aninteraction region 500, which includes or is made up of anelectromagnetically responsive control element, can be expanded byunfolding to the form depicted in FIG. 13B. Interaction region 500 has apleated structure that includes ridges 502 a-502 e and valleys 504 a-504d. Reaction sites 506 may be located in or on ridges 502 a-502 e andvalleys 504 a-504 d. In the folded form illustrated in FIG. 13A,reaction sites 506 located in valleys 504 a-504 d are ‘hidden’ in thesense that reactants may not fit into the narrow valleys to approachthose reaction sites, while reaction sites on ridges 502 a-502 e remainexposed. When interaction region 500 is unfolded to the form shown inFIG. 13B, reaction sites 506 in valleys 504 a-506 d are exposed, becausethe open valleys permit access of reactants to the reaction sites in thevalleys. Examples of materials that unfold in response toelectromagnetic fields include ionic polymer-metal composites (IPMC) asdescribed in Shahinpoor et al., “Artificial Muscle Research Institute:Paper: Ionic Polymer-Metal Composites (IPMC) As Biomimetic Sensors,Actuators and Artificial Muscles-A Review”; University of New Mexico;printed on Oct. 21, 2005; pp. 1-28; which is incorporated herein byreference.

Increasing the surface area of the interaction region may decrease therate of the interaction in some circumstances and increase the rate ofinteraction in others. Exposure of additional portions of theinteraction region may expose additional functional groups that are notreaction sites, but that may produce some local modification to asurface property of the interaction region that in turn modifies therate or kinetics of the reaction. For example, exposed functional groupsmay produce at least a local change in pH, surface energy, or surfacecharge. See, for example, U.S. patent publication 2003/0142901 A1, whichis incorporated herein by reference. A related modification of theinteraction region may include an increase in porosity or decrease indensity of an electromagnetically responsive control element. Anincrease in porosity may have a similar effect to unfolding with respectto modifying the spacing or exposure of reaction sites, functionalgroups, etc. See, for example U.S. Pat. Nos. 5,643,246, 5,830,207, and6,755,621, all of which are incorporated herein by reference. FIGS. 14Aand 14B depict an electromagnetically responsive control element 530that expands in response to an electromagnetic control signal, with acorresponding increase in size of pores 532 in FIG. 14B relative to thesize of pores 532 in FIG. 14A.

A change in the spacing of interaction sites may increase or decreasethe rate of interaction, or modify another parameter of an interaction,in a manner that depends on the specific reaction and reactants. Heatingor cooling of a reaction volume may also modify a chemical reaction bymodifying the pressure or the pH or the osmolality or otherreaction-pertinent chemical variables within the reaction space. In someembodiments, a delivery device may include at least one interactionregion capable of interacting with the primary material by one or moreof binding, reacting, interacting, or forming a complex with the primarymaterial. The at least one interaction region may be responsive to theelectromagnetic control signal by a change in at least onecharacteristic, the change in the at least one characteristic modifyingthe interaction between the at least one interaction region and theprimary material. For example, the at least one characteristic mayinclude at least one solubility, reactivity, temperature, conformation,orientation, alignment, binding affinity, chemical potential, surfaceenergy, porosity, osmolality, pH, distribution within the deliveryreservoir, or density. In some embodiments, at least a portion of thedelivery reservoir containing the at least one interaction region may beresponsive to an electromagnetic control signal by a change in thesurface area of the portion of the delivery reservoir, the change insurface area modifying the likelihood of interaction of the primarymaterial with the at least one interaction region. For example, thechange of surface area may be produced by stretching or expansion of theportion of the delivery reservoir, or by unfolding of the portion of thedelivery reservoir.

The influence of modifying the surface area of an interaction region isdescribed further in connection with FIGS. 15A and 15B and 16A and 16B.FIGS. 15A and 15B illustrate how an increase of the surface area of aninteraction region by stretching or expansion may increase the rate ofthe interaction occurring at the interaction region. Multipleinteraction sites 552 are located in interaction region 550. As shown inFIG. 15A, prior to stretch or expansion, interaction sites 552 are closetogether, and primary material 554, which binds to the interaction sites552, is sufficiently large that it is not possible for reactant 554 tobind to each interaction site 552. When interaction region 550 has beenstretched or expanded to expanded form 550′ as depicted in FIG. 15B, sothat the interaction sites 552 are further apart, it is possible forprimary material 554 to bind to a larger percentage of the interactionsites, thus increasing the rate of interaction.

In some embodiments, an increase in the surface area of the interactionregion by stretching or expansion may decrease the interaction rate (forexample, in cases where a particular spacing is needed to permit bindingor association of primary material with several interaction sitessimultaneously). FIGS. 16A and 16B illustrate how an increase in thesurface area of an interaction region 570 by stretching or expansion maydecrease the rate of the interaction occurring at the interactionregion. Again, multiple interaction sites 572 and 574 are located in theinteraction region 570, as depicted in FIG. 16A. In the present examplebinding of a primary material 576 to interaction region 570 requiresbinding of a primary material 576 to two interaction sites 572 and 574.When interaction region 570 is stretched or expanded to expanded form570′ as depicted in FIG. 16B, the spacing of the two interaction sites572 and 574 is changed so that primary material 576 does not readilybind to interaction region in the expanded form 570′, thus reducing therate of interaction.

Many materials expand when thermal energy is applied. By combiningmaterials as in polymer gels one can use the differing properties ofindividual components to affect the whole. Thermally-responsivematerials include thermally responsive gels (hydrogels) such asthermosensitive N-alkyl acrylamide polymers, Poly(N-isopropylacrylamide)(PNIPAAm), biopolymers, crosslinked elastin-based networks, materialsthat undergo thermally triggered hydrogelation, memory foam, resincomposites, thermochromic materials, proteins, memory shape alloys,plastics, and thermoplastics. Materials that contract or fold inresponse to heating may include thermally-responsive gels (hydrogels)that undergo thermally triggered hydrogelation (e.g. Polaxamers,uncross-linked PNIPAAm derivatives, chitosan/glycerol formulations,elastin-based polymers), thermosetting resins (e.g. phenolic, melamine,urea and polyester resins), dental composites (e.g.monomethylacrylates), and thermoplastics.

Some examples of reactions that may be sped up by change in distancebetween reaction sites include those involving drugs designed withspacers, such as dual function molecules, biomolecules linked totransition metal complexes as described in Paschke et al, “Biomoleculeslinked to transition metal complexes—new chances for chemotherapy”;Current Medicinal Chemistry; bearing dates of October 2003 and Oct. 18,2005, printed on Oct. 24, 2005; pp. 2033-44 (pp. 1-2); Volume 10, Number19; PubMed; and Schiff bases as described in Puccetti et al., “Carbonicanhydrase inhibitors”, Bioorg. Med. Chem. Lett. Jun. 15, 2005; 15(12):3096-101 (Abstract only), both of which are incorporated herein byreference. Other reactions include reactions responding toconformational (allosteric) changes including regulation by allostericmodulators, and reactions involving substrate or ligand cooperativity inmultiple-site proteins, where binding affects the affinity of subsequentbinding, e.g., binding of a first O₂ molecule to Heme increases thebinding affinity of the next such molecule, or influence of Tau onTaxol, as described in Ross et al., “Tau induces cooperative Taxolbinding to microtubules”; PNAS; Bearing dates of Aug. 31, 2004 and 2004;pp. 12910-12915; Volume 101, Number 35; The National Academy of Sciencesof the USA; which is incorporated herein by reference. Reactions orinteractions that may be slowed down by increased reaction site spacinginclude reactions responsive to conformational (allosteric) changes,influence or pH, or crosslinking. See for example Boniface et al.,“Evidence for a Conformational Change in a Class II MajorHistocompatibility Complex Molecule Occuring in the Same pH Range WhereAntigen Binding Is Enhanced”; J. Exp. Med.; Bearing dates of January1996 and Jun. 26, 2005; pp. 119-126; Volume 183; The RockefellerUniversity Press; also incorporated herein by reference or Sridhar etal., “New bivalent PKC ligands linked by a carbon spacer: enhancement inbinding affinity”; J Med Chem.; Bearing dates of Sep. 11, 2003 and Oct.18, 2005, printed on Oct. 24, 2005; pp. 4196-204 (pp. 1-2); Volume 46,Number 19; PubMed (Abstract); also incorporated herein by reference.

In some embodiments, the interaction region may include interactionsites that include a secondary material capable of interacting with orinfluencing the solubility of the primary material. Theelectromagnetically responsive control element may modify the influenceof the secondary material. In some embodiments the secondary materialmay not be localized to an interaction region, but may be distributedwithin the delivery reservoir, but responsive to an electromagneticcontrol signal. The secondary material may interact with or influenceprimary material in a variety of ways. As a first example, the secondarymaterial may be a receptor or other binding location that binds orsequesters the primary material, either specifically ornon-specifically, to take it out of solution. FIGS. 17A and 17B depictan interaction between primary material 600 and secondary material 602in interaction region 604. In FIG. 17A, prior to activation ofelectromagnetically responsive control element 606, primary material 600does not bind to secondary material 602 in interaction region 604.Following activation of electromagnetically responsive control element606, secondary material 602 undergoes a change to modified form 602′ asdepicted in FIG. 17B, which allows primary material 600 to bind to itand go out of solution, thus reducing the effective concentration of theprimary material in the delivery fluid.

In the example shown in FIGS. 18A and 18B, secondary material 630 is notitself a receptor or binding site for the primary material 632, butmodifies interaction between the primary material 632 and an interactionsite 634 (which may be, for example, a binding or receptor site) ininteraction region 636. In FIG. 18A, the secondary material 630 is in afirst configuration which blocks access of primary material 632 tointeraction site 634. In FIG. 18B, under the influence ofelectromagnetically responsive control element 638, secondary material630 has assumed a second configuration 630′ which permits access ofprimary material 632 to interaction site 634. Secondary material 630 maybe a material that modifies the rate or nature of the interactionbetween primary material 632 and interaction site 634 in response to anelectromagnetic control signal by steric effects, by modifying thepolarity of at least a portion of an interaction region, such as e.g.,hydrophobic or hydrophilic groups; by modifying the pH of at least aportion of the interaction region, with acids or acidifiers (e.g.,ammonium chloride), bases or alkalizers (sodium bicarbonate, sodiumacetate) or buffering agents (e.g., mono- or di-hydrogen phosphates); orit may be a material that modifies the charge of at least a portion ofthe interaction region, such as including various enzyme, neuraminidase,transferase, antioxidants, and charge donors.

In the example of FIGS. 19A and 19B, secondary material 640 is areactant that reacts with primary material 642 to produce reactionproduct 644. Primary material 642 approaches secondary material 640 ininteraction region 646 in FIG. 19A, and reaction product 644 leavesinteraction region 646 in FIG. 19B. The reaction between secondarymaterial 640 and primary material 642 is caused, produced, facilitated,or otherwise increased or enhanced by activation of electromagneticallyresponsive control element 648, (e.g., to produce heating, cooling, achange in surface charge, conformation, etc.) Reaction product 646 mayhave a different effective concentration in the delivery fluid thanprimary material 642 due to different solubility, or chemical activity,for example, or because the reaction results in an increase or decreasein the number of chemically active molecules in the reaction chamber. Areaction by-product 610 may remain at interaction region 646, asdepicted in FIG. 19B, or secondary material 640 may be completelyconsumed by the reaction.

The influence of the electromagnetically responsive control element inthe examples depicted in FIGS. 17A-19B may be any of various influences,including but not limited to those described herein; e.g., modifying thetemperature of the interaction region or exposing reaction sites orfunctional groups. The interaction that takes place at the interactionregion may change the effective concentration of primary material withinthe delivery reservoir by producing reaction products in differentquantities or with different solubility or chemical activity than thereactants. In some embodiments, the interaction region may include acatalyst that facilitates a chemical reaction but is not modified by thechemical reaction, for example, metals such as platinum, acid-basecatalysts, catalytic nucleic acids such as ribozymes or DNAzymes. Theinteraction region may include an enzyme, such as an oxidoreductase(e.g. glucose oxidase), transferase (including glycosyltransferase,kinase/phosphorylase), hydrolase, lyase, isomerase, ligase, andenzymatic complexes and/or cofactors. Various examples of catalysts areprovided in Kozhevnikov, “Catalysts for Fine Chemical Synthesis, Volume2, Catalysis by Polyoxometalates”; Chipsbooks.com; Bearing dates of 2002and 1998-2006, printed on Oct. 21, 2005; pp 1-3 (201 pages); Volume 2;Culinary and Hospitality Industry Publications Services; which isincorporated herein by reference.

Modifying a reaction condition at the interaction region may also beaccomplished by heating or cooling at least a portion of the interactionregion, or by modifying the osmolality or pH, surface charge, or surfaceenergy of at least a portion of the interaction region. Similarly,modifying a reaction condition at the interaction region may includemodifying a parameter of a reaction space within the delivery device,the reaction space containing the interaction region, e.g. by modifyingthe volume of the reaction space, heating or cooling at least a portionof the reaction space, or modifying the osmolality, pH, pressure,temperature, chemical composition, or chemical activity of at Least aportion of the reaction space.

In some embodiments, expansion or other conformation change of anelectromagnetically responsive control element may produce othermodifications to a condition in the delivery reservoir. For example, avolume of a delivery reservoir containing the interaction region may beincreased by expansion of an electromagnetically responsive controlelement, as depicted in FIGS. 20A and 20B. Delivery device 650 includesdelivery reservoir 652 containing primary material 654 and deliveryfluid 656 and having a first volume as shown in FIG. 20A. Anelectromagnetically responsive control element 658 that changesdimension in response to an electromagnetic control signal forms anexpandable portion of the wall of delivery reservoir 652. Upon expansionof electromagnetically responsive control element to expanded form 658′shown in FIG. 20B, the volume of delivery reservoir 652 is increased,and the concentration of primary material 654 within delivery reservoir652 is thus decreased. In this and other embodiments, the deliverydevice may include at least one sensor 660 for detecting at least oneparameter from the delivery reservoir. For example, the sensor maydetect a quantity or concentration of primary material in the deliveryreservoir. In other embodiments, the delivery device may include atleast one sensor for detecting a concentration or activity of a chemicalwithin at least a portion of an environment surrounding the deliverydevice. Examples of sensors are described in, U.S. Pat. No. 6,935,165,and U.S. Patent Publication 2004/0007051, both of which are incorporatedherein by reference.

FIG. 21 depicts in schematic form an embodiment of a delivery device 700including an electromagnetically responsive control element 702 thatincludes an active portion 704 and a power receiving structure 706.Delivery device also includes delivery reservoir 708 and outlet 710.Power receiving structure 706 may be any structure that has a size,shape, and material that is suitable for receiving and transducingelectromagnetic energy of a particular frequency or frequency band. Thepower receiving structure may include an antenna. The power receivingstructure may include a resonant structure. The resonant structure maybe a resonant circuit, a molecular bond, or a mechanically resonantstructure. In some embodiments, power receiving structure 706 may behighly frequency-selective, while in other embodiments it may reactusefully over a wide frequency band, or over multiple frequency bands.Power receiving structure 706 may be formed of various metallic orelectrically or magnetically active materials. Active portion 704 mayinclude various materials that respond mechanically, thermally orchemically to electromagnetic energy received and transduced by powerreceiving structure 706 to influence the effective concentration ofprimary material in delivery reservoir.

FIG. 22 depicts an embodiment of a delivery device 750 including an RFID752. Delivery device 750 includes delivery reservoir 754, outlet 756 andelectromagnetically responsive control element 758. RFID 752 may store aunique identification code that allows delivery device 750 to beidentified by a remote controller (not shown) that includes RFIDdetection circuitry. This provides for selective control of particulardelivery devices, for example.

Delivery devices as described herein may be configured for use in avariety of environments. A delivery device of the type disclosed hereinmay include a body structure (e.g., body structure 38 in FIGS. 2 and 3)adapted for positioning in an environment selected from a body of anorganism, as depicted in FIG. 1, or a body of water, or a containedfluid volume. The delivery reservoir may be located within the bodystructure. The body structure adapted for positioning in a containedfluid volume selected from an industrial fluid volume, an agriculturalfluid volume, a swimming pool, an aquarium, a drinking water supply, apotable water supply, and an HVAC system cooling water supply.

Various embodiments may be used in connection with selected biomedicalapplications (e.g., with delivery devices adapted for placement in thebody of a human or other animal). It is also contemplated that deliverysystems as described herein may be used in a variety of environments,not limited to the bodies of humans or other animals. Delivery devicesmay be placed in other types of living organisms (e.g., plants). Theenvironments for use of embodiments described herein are merelyexemplary, and the delivery systems as disclosed herein are not limitedto use in the applications presented in the examples.

FIG. 23 illustrates an exemplary embodiment of a delivery system 770 inwhich a delivery device 772 is located in a small enclosed fluid volume774 (e.g., an aquarium). A remote controller 776 is located outsideenclosed fluid volume 774.

FIG. 24 illustrates a further exemplary embodiment of a delivery system780 in which a delivery device 782 is located in a larger enclosed fluidvolume 784 (which may be, for example, a water storage tank, an HVACsystem cooling water tank, a tank containing an industrial fluid or anagricultural fluid). A remote controller 786 is located outside enclosedfluid volume 784.

FIG. 25 illustrates a further exemplary embodiment of a delivery system790 in which a delivery device 792 is located in a body of water 794 (alake or pond is depicted here, but such delivery systems may also bedesigned for use in rivers, streams, or oceans). A remote controller 796is shown located outside of body of water 794, though in someembodiments it may be advantageous to place remote controller 796 at alocation within body of water 794.

The body structure of the delivery device may be adapted for a specificenvironment. The size, shape, and materials of the body structureinfluence suitability for a particular environment. For example, adevice intended for use in a body of a human or other organism wouldtypically have suitable biocompatibility characteristics. For use in anyenvironment, the body structure (and device as a whole) may be designedto withstand environmental conditions such as temperature, chemicalexposure, and mechanical stresses. Moreover, the body structure mayinclude features that allow it to be placed or positioned in a desiredlocation in the environment, or targeted to a desired location in theenvironment. Such features may include size and shape features, tethersor gripping structures to prevent movement of the body structure in theenvironment (in the case that the device is placed in the desiredlocation) or targeting features (surface chemistry, shape, etc.) thatmay direct the device toward or cause it to be localized in a desiredlocation. The body structure may include a tissue-specific marker ortargeting molecule. For example, the tissue specific marker or targetingmolecule may be a tissue specific endothelial protein. Small devices(e.g. as may be used for placement in the body of an organism) may beconstructed using methods known to those in skill of the art ofmicrofabrication. In applications where size is not a constraint, a widevariety of fabrication methods may be employed. The body structure ofthe delivery device may be formed from various materials or combinationsof materials, including but not limited to plastics and other polymers,ceramics, metals, and glasses, and by a variety of manufacturingtechniques.

In some embodiments, the delivery device may be a MEMS device or othermicrofabricated device. The delivery device may be constructed from atleast one polymer, ceramic, glass, or semiconductor material. In someembodiments, the delivery device may be a battery-free device, poweredby power beaming, inductive coupling, or an environmental power source.In still other embodiments, the device may include a battery or otheron-board power source. In some embodiments, the delivery device mayinclude an electromagnetic control signal generator, which may belocated substantially in, on or adjacent to the delivery reservoir. Inother embodiments, the electromagnetic control signal generator may belocated at a location remote from the delivery reservoir.

As discussed herein, a remote controller for a delivery device mayinclude an electromagnetic signal generator capable of producing anelectromagnetic signal sufficient to activate an electromagneticallyresponsive control element of a delivery device located in anenvironment to change a concentration of a primary material within adelivery reservoir of the delivery device; and an electromagnetic signaltransmitter capable of wirelessly transmitting the electromagneticsignal to the electromagnetically responsive control element. Varioustypes and frequencies of electromagnetic control signals may be used indelivery systems as described herein. For example, in some embodiments,the delivery system may include a remote controller configured togenerate a static or quasi-static electrical field control signal orstatic or quasi-static magnetic field control sufficient to activate theelectromagnetically responsive control element to control the effectiveconcentration of primary material in a desired manner. In otherembodiments, the remote controller may be configured to generate aradio-frequency, microwave, infrared, millimeter wave, optical, orultraviolet electromagnetic field control signal sufficient to activatethe electromagnetically responsive control element to control theeffective concentration of primary material in a desired manner.

The electromagnetic control signal may be produced based at least inpart upon a predetermined activation pattern. As shown in FIG. 26, apredetermined activation pattern may include a set of stored data 1002a, 1002 b, 1002 c, 1002 d, . . . 1002 e, having values f(t1), f(t2),f(t3), f(t4), . . . f(t_(N)), stored in a memory location 1000. Theactivation pattern upon which the electromagnetic signal is based isdepicted in plot 1004 in FIG. 26. In plot 1004, time t_(n) is indicatedon axis 1006 and signal amplitude f(t_(n)), which is a function oft_(n), is indicated on axis 1008. The value of the electromagneticsignal over time is represented by trace 1010. The predeterminedactivation pattern represented by data 1002 a, 1002 b, 1002 c, 1002 d, .. . 1002 e may be based upon calculation, measurements, or any othermethod that may be used for producing an activation pattern suitable foractivating an electromagnetically responsive control element. Memory1000 may be a memory location in a remote controller. As an example, asimple remote controller may include a stored activation pattern inmemory and include electrical circuitry configured to generate anelectromagnetic control signal according to the pattern for a presetduration or at preset intervals, without further input of eitherfeedback information or user data. In a more complex embodiment, apredetermined activation pattern may be generated in response to certainfeedback or user input conditions.

In some embodiments, an electromagnetic signal may be produced basedupon a model-based calculation. As shown in FIG. 27, an activationpattern f(t_(n)) may be a function not only of time (t_(n)) but also ofmodel parameters P₁, P₂, . . . P_(k), as indicated by equation 1050.Data 1052 a, 1052 b, . . . 1052 c having values P₁, P₂, . . . P_(k) maybe stored in memory 1054. An electromagnetic control signal may becomputed from the stored model parameters and time information. Forexample, as indicated in plot 1056, time is indicated on axis 1058 andthe strength or amplitude of the electromagnetic control signal isindicated on axis 1060, so that trace 1061 represents f(t_(n)). Memory1054 may be a memory location in a remote controller. The remotecontroller may generate an electromagnetic control signal based upon thestored function and corresponding parameters. In some embodiments, theelectromagnetic control signal may also be a function of one or morefeedback signals (from the delivery device or the environment, forexample) or of some user input of data or instructions.

FIG. 28 depicts a remote controller 1100 having a memory 1104 capable ofstoring pre-determined data values or parameters used in model-basedcalculation, as described in connection with FIGS. 29 and 30. Remotecontroller 1100 may also include electrical circuitry 1102, signalgenerator 1112, and signal transmitter 1114 for transmittingelectromagnetic control signal 1116. Memory 1104 may include memorylocation 1106 for containing a stored activation pattern or modelparameters; portions of memory 1104 may also be used for storingoperating system, program code, etc. for use by processor 1102. Thecontroller 1100 may also include a beam director 1118, such as anantenna, optical element, mirror, transducer, or other structure thatmay impact control of electromagnetic signaling. The electricalcircuitry may include any or all of analog circuitry, digital circuitry,one or more microprocessors, computing devices, memory devices, and soforth. Remote controller may include at least one of hardware, firmware,or software configured to control generation of the electromagneticcontrol field signal. Software may include, for example, instructionsfor controlling the generation of the electromagnetic control signal andinstructions for controlling the transmission of the electromagneticcontrol signal to the electromagnetically responsive control element.

Remote controller 1100 may be configured to produce an electromagneticcontrol signal having various characteristics, depending upon theintended application of the system. Design specifics of electricalcircuitry, signal generator, and signal transmitter will depend upon thetype of electromagnetic control signal. The design of circuitry andrelated structures for generation and transmission of electromagneticsignals can be implemented using tools and techniques known to those ofskill in the electronic arts. See, for example, Electrodynamics ofContinuous Media, 2nd Edition, by L. D. Landau, E. M. Lifshitz and L. P.Pitaevskii, Elsevier Butterworth-Heinemann, Oxford, especially but notexclusively pp. 1-13- and 199-222, which is incorporated herein byreference, for discussion of theory underlying the generation andpropagation of electrical, magnetic, and electromagnetic signals.

Remote controller 1100 may be configured to produce an electromagneticcontrol signal having various characteristics, depending upon theintended application of the system. In some embodiments, a specificremote controller may be configured to produce only a specific type ofsignal (e.g., of a specific frequency or frequency band) while in otherembodiments, a specific remote controller may be adjustable to produce asignal having variable frequency content. Signals may include componentswhich contribute a DC bias or offset in some cases, as well as ACfrequency components. Generation of radio frequency electromagneticsignals is described, for example, in the The ARRL Handbook for RadioCommunications 2006, R. Dean Straw, Editor, published by ARRL,Newington, Conn., which is incorporated herein by reference.Electromagnetic signal generator 1112 may be capable of producing anelectromagnetic control signal sufficient to activate anelectromagnetically responsive control element of a delivery devicelocated in an environment to change an effective concentration of aprimary material in a delivery fluid within a fluid-containing structureof the delivery device; and an electromagnetic signal transmittercapable of wirelessly transmitting the electromagnetic control signal tothe electromagnetically responsive control element of a delivery devicein an environment. Signal transmitter 1114 may include a sending devicewhich may be, for example, an antenna or waveguide suitable for use withan electromagnetic signal. Static and quasistatic electrical fields maybe produced, for example, by charged metallic surfaces, while static andquasistatic magnetic fields may be produced, for example, by passingcurrent through one or more wires or coils, or through the use of one ormore permanent magnets, as known to those of skill in the art. As usedherein, the terms transmit, transmitter, and transmission are notlimited to only transmitting in the sense of radiowave transmission andreception of electromagnetic signals, but are also applied to wirelesscoupling and/or conveyance of magnetic signals from one or more initiallocations to one or more remote locations.

The remote controller may be modified as appropriate for its intendeduse. For example, it may be configured to be wearable on the body of ahuman (or other organism) in which a delivery device has been deployed,for example on a belt, bracelet or pendant, or taped or otherwiseadhered to the body of the human. Alternatively, it may be configured tobe placed in the surroundings of the organism, e.g., as a table-topdevice for use in a home or clinical setting.

In various embodiments, the delivery device may include a remotecontroller configured to generate a static or quasi-static electricalfield control signal, a static or quasi-static magnetic field controlsignal, a radio-frequency electromagnetic control signal, a microwaveelectromagnetic control signal, an infrared electromagnetic controlsignal, a millimeter wave electromagnetic control signal, an opticalelectromagnetic control signal, or an ultraviolet electromagneticcontrol signal sufficient to activate the electromagnetically responsivecontrol element to control the effective concentration of the primarymaterial in the delivery fluid.

Various types of electromagnetic field control signals may be used toactivate the electromagnetically responsive control element. Theelectromagnetically responsive control element may be responsive to astatic or quasi-static electrical field or a static or quasi-staticmagnetic field. It may be responsive to various types of non-ionizingelectromagnetic radiation, or in some cases, ionizing electromagneticradiation. Electromagnetic field control signals that may be used invarious embodiments include radio-frequency electromagnetic radiation,microwave electromagnetic radiation, infrared electromagnetic radiation,millimeter wave electromagnetic radiation, optical electromagneticradiation, or ultraviolet electromagnetic radiation.

The electromagnetic signal generator may include electrical circuitryand/or a microprocessor. In some embodiments, the electromagnetic signalmay be produced at least in part according to a pre-determinedactivation pattern. The remote controller may include a memory capableof storing the pre-determined activation pattern. In some embodiments,the electromagnetic signal may be produced based on a model-basedcalculation; the remote controller may include a memory capable ofstoring model parameters used in the model-based calculation.

In some embodiments, the remote controller may produce anelectromagnetic signal having one or both of a defined magnetic fieldstrength or defined electric field strength. In general, the term fieldstrength, as applied to either magnetic or electric fields, may refer tofield amplitude, squared-amplitude, or time-averaged squared-amplitude.The electromagnetic signal may have signal characteristics sufficient toproduce a change in dimension of the electromagnetically responsivecontrol element, a change in temperature of the electromagneticallyresponsive control element, a change in conformation of theelectromagnetically responsive control element, or a change inorientation or position of the electromagnetically responsive controlelement. In some embodiments, the electromagnetic signal generator mayinclude an electromagnet or electrically-polarizable element, or atleast one permanent magnet or electret. The electromagnetic signal maybe produced at least in part according to a pre-programmed pattern. Theelectromagnetic signal may have signal characteristics sufficient toproduce a change in dimension in the electromagnetically responsivecontrol element, the change in dimension causing a change in theconcentration of the primary material within the delivery reservoir ofthe delivery device. It may have signal characteristics sufficient toproduce a change in temperature of the electromagnetically responsivecontrol element, the change in temperature causing a change in theconcentration of the primary material within the delivery reservoir ofthe delivery device. In some embodiments, it may have signalcharacteristics sufficient to produce a change in one or more of shape,volume, surface area or configuration of the electromagneticallyresponsive control element, the change in dimension in one or more ofshape, volume, surface area or configuration of the electromagneticallyresponsive control element causing a change in the concentration of theprimary material within the delivery reservoir of the delivery device.The electromagnetic signal may have signal characteristics sufficient toproduce a change in shape in an electromagnetically responsive controlelement including a shape memory material, a bimetallic structure, or apolymeric material. The electromagnetic signal may have a definedmagnetic field strength or spatial orientation, or a defined electricfield strength or spatial orientation.

In some embodiments, the remote controller may be configured to generateand transmit an electromagnetic control signal having at least one offrequency and orientation that are selectively receivable by the atleast one magnetically responsive control element. In some embodiments,the remote controller may include at least one of hardware, software, orfirmware configured to perform encryption of electromagnetic controlsignal to produce an encrypted electromagnetic control signal.

FIG. 29 depicts an example of an electromagnetic waveform of a type thatmay be used to activate and electromagnetically responsive controlelement. In plot 1150, time is plotted on axis 1152, and electromagneticfield strength is plotted on axis 1154. Trace 1156 has the form of asquare wave, switching between zero amplitude and a non-zero amplitude,A.

FIG. 30 depicts another example of an electromagnetic waveform. In plot1200, time is plotted on axis 1202, and electromagnetic field strengthis plotted on axis 1204. Trace 1206 includes bursts 1208 and 1210,during which the field strength varies between A and −A, at a selectedfrequency, and interval 1212, during which field strength is zero.

FIG. 31 depicts another example of an electromagnetic waveform. In plot1250, time is plotted on axis 1252, and electromagnetic field strengthis plotted on axis 1254. Trace 1256 includes bursts 1258, and 1262,during which the field strength varies between A and −A at a firstfrequency, and burst 1260, during which the field strength variesbetween B and −B at a second (lower) frequency. Different frequenciesmay be selectively received by certain individuals or classes ofelectromagnetically responsive control elements within a device orsystem including multiple electromagnetically responsive controlelements. An electromagnetic control signal may be characterized by oneor more frequencies, phases, amplitudes, or polarizations. Anelectromagnetic control signal may have a characteristic temporalprofile and direction, and characteristic spatial dependencies.

The magnetic or electric field control signal produced by the remotecontroller may have one or both of a defined magnetic field strength ora defined electric field strength. At low frequencies the electrical andmagnetic components of an electromagnetic field are separable when thefield enters a medium. Therefore, in static and quasi-static fieldapplication, the electromagnetic field control signal may be consideredas an electrical field or a magnetic field. A quasi-static field is onethat varies slowly, i.e., with a wavelength that is long with respect tothe physical scale of interest or a frequency that is low compared tothe characteristic response frequency of the object or medium;therefore, the frequency beyond which a field will no longer beconsidered ‘quasi-static’ is dependent upon the dimensions orelectrodynamic properties of the medium or structure(s) influenced bythe field.

As depicted in various embodiments, e.g., as shown in FIGS. 6A-10B, thedelivery reservoir may include an outlet through which the deliveryfluid moves into an environment, for example by pumping or diffusion. Inother embodiments, as depicted in FIG. 32, a delivery system 1300 mayinclude a downstream fluid handling structure 1302 in fluidcommunication with the delivery reservoir 1304 and configured to receivefluid 1306 ejected from the delivery reservoir 1304 in response to thechange in at least one of pressure or volume in the delivery reservoir1304. The downstream fluid handling structure 1302 may include achamber, as depicted in FIG. 32. Delivery device 1300 may also include apump (e.g., and osmotic pump 1308) and an electromagnetically responsivecontrol element 1310.

In other embodiments, e.g. delivery device 1350 shown in FIG. 33, adownstream fluid handling structure 1352 may include one or morechannels 1354, chambers 1356, splitters 1358, mixers 1360, or otherfluid handling structures, or various combinations thereof. Deliverydevice 1350 also includes pump 1362, delivery reservoir 1364, and outlet1366. Examples of fluid handling structures suitable for use in selectedembodiments are described in U.S. Pat. Nos. 6,146,103 and 6,802,489, andin Krauβ et al., “Fluid pumped by magnetic stress”; Bearing a date ofJul. 1, 2004; pp. 1-3; all of which are incorporated herein byreference. Fluid handling structures may include, but are not limitedto, channels, chambers, valves, mixers, splitters, accumulators,pulse-flow generators, and surge-suppressors, among others.

Previously described embodiments of delivery devices have include adelivery reservoir that is substantially chamber-like in shape. However,delivery fluid may be contained in fluid-containing structures havingvarious shapes and configurations. FIG. 34 illustrates a delivery device1400 that includes a fluid-containing structure 1402 that takes the formof a channel. The fluid-containing structure 1402 may have at least oneoutlet 1404 through which a fluid may exit the fluid-containingstructure 1402 to a downstream location; a delivery fluid 1406 containedwithin the fluid-containing structure 1402; a primary material containedwithin the fluid-containing structure and having a controllableeffective concentration in the delivery fluid; at least oneelectromagnetically responsive control element adapted 1408 forcontrolling the distribution of the primary material between a firstactive form 1410 carried in the delivery fluid and a second form 1412 inresponse to an incident electromagnetic control signal, the effectiveconcentration being the concentration of the first active form in thedelivery fluid; and a pump 1414 configured for pumping delivery fluidfrom the fluid-containing structure to the downstream location.

As noted previously, delivery devices as described herein may includevarious types of pumps. A pump suitable for use in a delivery device mayinclude a mechanical pump, a displacement pump, a centrifugal pump, or aperistaltic pump. The choice of pump and method of construction thereofmay depend upon the intended use of the delivery device, the deliverysite, the dimensions of the delivery device, among other factors, aswill be apparent to those of skill in the art. In some embodiments, thedownstream location may be an environment. In some embodiments, thedownstream location may be a downstream fluid handling structure, and insome embodiments, the downstream location may include a downstreamenvironmental interface. An environmental interface may function tofacilitate the distribution of a primary material into an environment.

FIG. 35 depicts an example of a delivery device 1450 including anenvironmental interface 1452. In the example of FIG. 35, theenvironmental interface 1452 provides for the delivery of primarymaterial 1454 into blood flowing through capillaries 1456. Deliverydevice 1450 includes pump 1458 and a fluid-containing structure 1460(here depicted as a delivery reservoir) containing delivery fluid 1462carrying primary material 1454. Environmental interface 1452 includessubstrate material 1464 capable of supporting growth of capillaries1456. Distribution channel 1466 distributes delivery fluid 1462 tosubstrate material 1464, where primary material 1454 may diffuse intocapillaries 1456 and be picked up by the blood.

In other embodiments, a delivery device as depicted generally in FIG. 34may include any of various types of downstream fluid handlingstructures. The downstream fluid handling structure may include at leastone channel, of the type depicted in FIG. 33, or at least one chamber,for example as depicted in FIG. 32 or 33. The downstream fluid handlingstructure may include at least one mixer (e.g. 1360 in FIG. 33 or atleast one splitter (e.g. 1354 in FIG. 33). In some embodiments, thedownstream fluid handling structure may include a filter, for example,of the type depicted in FIG. 6D; it is contemplated that one or morefilter may be placed at various downstream locations, not only at theoutlet of the fluid-containing structure but potentially furtherdownstream instead, or in addition.

FIG. 36 depicts a method of delivery a fluid through the use of adelivery device as described herein. The basic method includes receivingan electromagnetic control signal from a remote controller at step 1502;and responsive to the electromagnetic control signal, modifying aneffective concentration of a primary material in a delivery fluid withina delivery reservoir at step 1504.

As shown in FIG. 37, an expanded version of the method may includereceiving an electromagnetic control signal from a remote controller atstep 1552; and responsive to the electromagnetic control signal,modifying an effective concentration of a primary material in a deliveryfluid within a delivery reservoir at step 1554; followed by anadditional step of 1556 of ejecting the delivery fluid from the deliveryreservoir.

FIG. 38 provides further detail on a method including receiving anelectromagnetic control signal from a remote controller at step 1602;and responsive to the electromagnetic control signal, modifying aneffective concentration of a primary material in a delivery fluid withina delivery reservoir at step 1604 (comparable to steps 1502 and 1504 asshown in FIG. 36). The method may include modifying the effectiveconcentration of the primary material in the delivery fluid by modifyingat least one characteristic of the delivery fluid, the effectiveconcentration of the primary material in the delivery fluid dependentupon the at least one characteristic of the delivery fluid, as shown inalternative step 1608 in FIG. 38. In this and other figures boxescontaining optional or alternative steps are surrounded by a dashedline. The at least one characteristic may include, for example,temperature, pH, polarity, osmolality or chemical activity. As anotheralternative, as indicated at alternative step 1612 in FIG. 38, themethod may include modifying the effective concentration of the primarymaterial in the delivery fluid by modifying at least one characteristicof the primary material, the solubility of the primary material in thedelivery fluid being dependent upon the at least one characteristic ofthe primary material. The at least one characteristic includestemperature, charge, polarity, osmolality, conformation, orientation, orchemical activity. As a further alternative, indicated at 1610 in FIG.38, the method may include modifying the effective concentration of theprimary material in the delivery fluid by modifying at least one of anumber of interaction sites in the delivery reservoir or an affinity ofat least one interaction site in the delivery reservoir for the primarymaterial. The affinity of the at least one interaction site for theprimary material may be modified by modifying the temperature, charge,polarity, osmolality, surface energy, orientation, conformation,chemical activity or chemical composition of the at least oneinteraction site or in the vicinity of the at least one interactionsite. The number of interaction sites may be modified by stretching,compressing, unfolding, or changing a conformation of at least a portionof the delivery reservoir, for example.

A method as shown in FIGS. 36-48 may include receiving theelectromagnetic control signal with an electromagnetically responsivematerial, which may include, for example, a permanently magnetizablematerial, a ferromagnetic material, a ferrimagnetic material, a ferrousmaterial, a ferric material, a dielectric or ferroelectric orpiezoelectric material, a diamagnetic material, a paramagnetic material,and an antiferromagnetic material. The method may include a step ofejecting the delivery fluid into an environment, which may include, forexample, the body of an organism, a body of water, or a contained fluidvolume. Alternative, the method may include ejecting the delivery fluidinto a downstream environmental interface or a downstream fluid-handlingstructure, which may include a channel, a chamber, a mixer, a separator,or combinations thereof.

FIG. 39 depicts a delivery system 1650 that includes a delivery device1652 and a remote controller 1654. Delivery device 1652 includesfluid-containing structure 1656 having at least one outlet 1658 throughwhich fluid may exit the fluid-containing structure 1656; a deliveryfluid 1660 contained within the fluid-containing structure 1656; aprimary material 1662 contained within the fluid-containing structure1656 and having a controllable effective concentration in the deliveryfluid 1660; and at least one electromagnetically responsive controlelement 1664 adapted for modifying the distribution of the primarymaterial 1662 between a first active form carried in the delivery fluidand a second form in response to an incident electromagnetic controlsignal to modify the effective concentration of the primary material inthe delivery fluid, the effective concentration being the concentrationof the first active form in the delivery fluid. Remote controller 1654includes an electromagnetic signal generator 1668 capable of producingan electromagnetic control signal sufficient to activate theelectromagnetically responsive control element 1664 of the deliverydevice 1652 located in an environment 1653 to change the effectiveconcentration of the primary material in the delivery fluid 1660 withinthe fluid-containing structure 1656 of the delivery device 1652; and anelectromagnetic signal transmitter 1670 capable of wirelesslytransmitting the electromagnetic control signal 1672 to theelectromagnetically responsive control element of the delivery device inthe environment. The remote controller may include electrical circuitry1674, which may include at least one of hardware, firmware, or softwareconfigured to control generation of the electromagnetic control signal.The remote controller 1654 may include an electromagnetic signalgenerator 1668 configured to generate a static or quasi-staticelectrical field control signal, a static or quasi-static magnetic fieldcontrol signal, a radio-frequency electromagnetic control signalsufficient, a microwave electromagnetic control, an infraredelectromagnetic control signal, a millimeter wave electromagneticcontrol signal, an optical electromagnetic control signal, or anultraviolet electromagnetic control signal sufficient to activate theelectromagnetically responsive control element to control the effectiveconcentration of the primary material within the fluid-containingstructure. The remote controller may include an electromagnetic signalgenerator configured to generate a rotating electromagnetic controlsignal.

Delivery device 1652 may include a body structure 1676 adapted forpositioning in an environment 1653 selected from a body of an organism,a body of water, or a contained fluid volume. For example, bodystructure 1676 may be adapted for positioning in a contained fluidvolume selected from an industrial fluid volume, an agricultural fluidvolume, a swimming pool, an aquarium, a drinking water supply, a potablewater supply, and an HVAC system cooling water supply. Delivery device1652 may include a pump 1678, as described generally elsewhere herein.

The electromagnetically responsive control element 1664 may include amagnetically or electrically active material including at least onepermanently magnetizable material, ferromagnetic material, ferrimagneticmaterial, ferrous material, ferric material, dielectric material,ferroelectric material, piezoelectric material, diamagnetic material,paramagnetic material, metallic material, or antiferromagnetic material.In some embodiments, the electromagnetically responsive control elementmay include a polymer, ceramic, dielectric, metal, shape memorymaterial, or a combination of a polymer and a magnetically orelectrically active component.

FIG. 40 depicts a delivery system 1700, including remote controller1702, and delivery device 1704. Delivery device 1704 includesfluid-containing structure 1656, having outlet 1658 and containingdelivery fluid 1660 and primary material 1662. Delivery device 1704 alsoincludes electromagnetically responsive control element 1664 forcontrolling the effective concentration of primary material 1662 indelivery fluid 1660. Delivery device 1704 may include body structure1676 adapted for placement in environment 1653, and pump 1678. Deliverydevice 1704 may also include RFID 1700. Remote controller 1702 includesRF interrogation signal generator 1706 for generating an RFinterrogation signal 1708, which may be tuned to the RFID. Remotecontroller 1702 includes electromagnetic signal generator 1668,electromagnetic signal transmitter 1670, electrical circuitry 1674,which function generally as described in connection with FIG. 39.

FIG. 41 illustrates a delivery system including a remote controller 1850that produces electromagnetic control signal 1852 that is transmitted todelivery device 1854 in environment 1856. Electromagnetic control signal1852 is received by electromagnetically responsive control element 1858in delivery device 1854. Remote controller 1850 may include a signalinput 1851 adapted for receiving a feedback signal 1860 sensed from anenvironment 1856 by a sensor 1862, wherein the electromagnetic signal1852 is produced based at least in part upon the feedback signal 1860sensed from the environment. For example, the feedback signal 1852 maycorrespond to the osmolality or the pH of the environment, theconcentration or chemical activity of a chemical in the environment, atemperature or pressure of the environment, or some other sensed signal.Remote controller 1850 may include electrical circuitry 1864, signalgenerator 1866, signal transmitter 1868, and memory 1870. Feedback fromsensor 1862 may be sent over a wire connection or, in some embodiments,transmitted wirelessly. Remote controller may include a signal inputadapted for receiving a feedback signal corresponding to one or moreparameters sensed from the environment, wherein the electromagneticcontrol signal is produced based at least in part upon the feedbacksignal sensed from the environment. For example, the feedback signalcorresponds to the concentration or chemical activity of a chemical inthe environment.

FIG. 42 illustrates another embodiment of a delivery system, includingremote controller 1900, which transmits electromagnetic control signal1902 to delivery device 1904 in environment 1906. Remote controller 1900may include a signal input 1908 adapted for receiving a feedback signal1912 from sensor 1910 in delivery device 1904. Electromagnetic controlsignal 1902 may be produced based at least in part upon the feedbacksignal 1912 corresponding to one or more parameters sensed from thedelivery device. In some embodiments, the feedback signal may correspondto the concentration or chemical activity of a chemical within or aroundthe delivery device. In some embodiments, the feedback signal from thedelivery device may correspond to the osmolality or the pH within oraround the delivery device, the concentration or chemical activity of achemical within or around the delivery device, a temperature or pressurewithin or around the delivery device, the pumping rate of the deliverydevice, or some other parameter sensed from the delivery device. Inothers, the feedback signal may correspond to the pumping rate of thedelivery device, produced, for example, by pump 1922. In someembodiments, sensor 1910 may be configured for detecting at least oneparameter from at least a portion of an environment surrounding thedelivery device. The electromagnetic signal 1902 may be determined basedat least in part upon the feedback signal 1912. Examples of sensors aredescribed in U.S. Pat. No. 6,935,165, and U.S. Patent Publication2004/0007051, both of which are incorporated herein by reference.Delivery device 1904 includes electromagnetically responsive controlelement 1920. Feedback signal 1912 may be transmitted wirelessly back toremote controller 1900. Remote controller 1900 may include processor1914, signal generator 1916, signal transmitter 1918, and memory 1924.

As illustrated in FIG. 43, in some embodiments, the remote controllermay be configured to receive user input of control parameters. Remotecontroller 1950 includes input 1960 for receiving input of informationor instructions from a user such as, for example, commands, variables,durations, amplitudes, frequencies, waveforms, data storage or retrievalinstructions, patient data, etc. As in the other embodiments, remotecontroller 1950 transmits electromagnetic control signal 1952 todelivery device 1954 in environment 1956, where it activateselectromagnetically responsive control element 1958. Input 1960 mayinclude one or more input devices such as a keyboard, keypad,microphone, mouse, etc. for direct input of information from a user, orinput 1960 may be any of various types of analog or digital data inputsor ports, including data read devices such as disk drives, memory devicereaders, and so forth in order to receive information or data in digitalor electronic form. Data or instructions entered via input 1960 may beused by electrical circuitry 1962 to modify the operation of remotecontroller 1950 to modulate generation of an electromagnetic controlsignal 1952 by signal generator 1964 and transmission of the controlsignal 1952 by transmitter 1966.

FIG. 44 illustrates a delivery system that includes a plurality ofdelivery devices, where two or more of the plurality of delivery devicesare controlled by the remote controller. A delivery device may include aplurality of selectively activatable control elements, each associatedwith a particular fluid handling element, which may thus be controlledto perform multiple fluid-handling or reaction steps in a particularsequence. It is also contemplated that a delivery system may include aplurality of delivery devices which may be of the same or differenttypes. As shown in FIG. 44, a delivery system 2000 may include aplurality of identical delivery devices 2002 distributed throughout anenvironment 2004 in order to perform a particular chemical reaction orprocess at a plurality of locations within the environment, andcontrolled by a remote controller 2006. Alternatively, a delivery systemmay include a plurality of different delivery devices at differentlocations within an environment, each performing or controlling areaction suited for the particular location. The invention as describedherein is not limited to devices or systems including any specificnumber or configuration of electromagnetically responsive controlelements within a delivery device, or specific number or configurationof delivery devices or remote controllers within a delivery system.Depending upon the particular application of a system,electromagnetically responsive control elements and/or delivery devicesmay be controlled in a particular pattern to producing a desireddistribution of a delivery material in an environment. Control of suchsystems may be performed with the use of suitable hardware, firmware, orsoftware, through one or a plurality of remote controllers.

The remote controller used in the system depicted in FIG. 44 may includean electromagnetic signal generator capable of producing anelectromagnetic control signal sufficient to activateelectromagnetically responsive control elements in a plurality ofdelivery devices located in an environment to change an effectiveconcentration of primary material in a delivery fluid within afluid-containing structure of each of the devices. In a relatedembodiment, the remote controller may include a plurality of signalinputs adapted for receiving signals from the plurality of deliverydevices, the plurality of signal inputs coupled to a microprocessorconfigured to generate the electromagnetic control signal based upon theplurality of signals.

Selective activation or control of electromagnetically responsivecontrol elements may be achieved by configuring electromagneticallyresponsive control elements to be activated by electromagnetic controlsignals having particular signal characteristics, which may include, forexample, particular frequency, phase, amplitude, temporal profile,polarization, and/or directional characteristics, and spatial variationsthereof. For example, different control elements may be responsive todifferent frequency components of a control signal, thereby allowingselective activation of the different control elements. The remotecontroller may be configured to produce a rotating electromagneticsignal, the rotating electromagnetic signal capable of activating thetwo or more delivery devices independently as a function of theorientation of the rotating electromagnetic signal.

As shown in FIG. 45, in still other embodiments, a delivery system 2050may include a delivery device 2052 that includes a plurality ofelectromagnetically responsive control elements 2054, responsive to oneor more remote controller 2056. A plurality of control elements 2054 maybe used, for example, to control a plurality of locations or functionsin delivery device 2052.

As shown in FIG. 46, in some embodiments, a delivery system 2101 or mayinclude a plurality of delivery devices 2102, 2104, 2106, and 2108, anda plurality of remote controllers 2100 a, 2100 b, 2100 c. As shown inFIG. 46, each delivery device may be controlled by one or more controlsignals produced in a distributed fashion by two or more of theplurality of remote controllers 2100 a-2100 c.

As shown in FIG. 47, in some embodiments a delivery system 2151 mayinclude a plurality of delivery devices 2152 a, 2152 b, and 2152 c and aplurality of remote controllers 2150 a, 2150 b, and 2150 c, eachdelivery device may be controlled by a separate remote controller, forexample delivery device 2152 a controlled by remote controller 2150 a,delivery device 2152 b controlled by remote controller 2150 b, anddelivery device 2152 c controlled by remote controller 2150 c.

In still other embodiments, as shown in FIG. 48, a remote controller2200 may include a plurality of transmission channels 2204 a, 2204 b,2204 c, and 2204 d, for example (more or fewer channels may be used,without limitation). Remote controller 2200 may also include channelallocation hardware or software 2206 configured to allocate usage of theplurality of transmission channels 2204 a-2204 d for the transmission ofthe electromagnetic control signal from signal transmitter 2208 toselected delivery devices of the plurality of delivery devices 2202a-2202 f.

In another embodiment of a delivery system 2250 shown in FIG. 49, theremote controller 2252 may include encryption hardware or software 2262configured to encrypt one or more control signal components, wherein theencrypted one or more control signal components are receivable by adelivery device 2254 including a corresponding decryption key 2264.Remote controller 2252 may include signal generator 2256, signaltransmitter 2258, and electrical circuitry 2260, as described generallyelsewhere.

In another embodiment of a delivery system 2300 shown in FIG. 50, theremote controller 2302 may include authentication hardware or software2312 configured to perform an authentication procedure with a deliverydevice 2304, wherein the remote controller 2302 is configured to produceactivation of the electromagnetically responsive control element 2316 ofan authenticated delivery device but not the electromagneticallyresponsive control element of a non-authenticated delivery device.Again, remote controller 2302 may include signal generator 2306, signaltransmitter 2308, and electrical circuitry 2310, as described generallyelsewhere, and authentication portion 2314, which may include hardware,firmware or software configured for performing an authenticationprotocol with remote controller 2302.

Referring back to FIG. 40, remote controller 1702 may include aninterrogation signal generator 1706 for generating a transmittable RFIDinterrogation signal. The remote controller may also include aninterrogation signal transmitter for transmitting the transmittable RFIDinterrogation signal; an interrogation signal receiver for receiving areturned RFID interrogation signal from an RFID in a delivery device;and RFID detection circuitry configured to detect the presence of aselected RFID from a returned RFID interrogation signal. Upon detectionof the presence of the selected RFID, to remote controller 1702 maygenerate and transmit a control signal configured for receipt by thedelivery device including the selected RFID.

In various embodiments of the remote controller described herein, thegenerated electromagnetic control signal may have a defined magneticfield strength, or alternatively, or in addition, a defined electricfield strength. Depending upon the intended application, theelectromagnetic control signal may have signal characteristicssufficient to produce a change in dimension of the electromagneticallyresponsive control element, a change in temperature of at least aportion of the electromagnetically responsive control element, a changein conformation or configuration of the electromagnetically responsivecontrol element, or a change in orientation or position of theelectromagnetically responsive control element. The remote controllermay include an electromagnetic signal generator that includes anelectromagnet or electrically-polarizable element, or at least onepermanent magnet or electret.

FIG. 51 depicts the steps of a method of delivering a material,comprising delivering an electromagnetic distribution control signal toan environment containing a delivery device, the delivery deviceincluding an electromagnetically responsive control element and afluid-containing structure containing a delivery fluid and a quantity ofa primary material distributed between a first active form carried inthe delivery fluid and a second form according to a first distribution,the primary material distributed according to the first distributionhaving a first effective concentration in the delivery fluid equal tothe concentration of the first active form in the delivery fluid, theelectromagnetic distribution control signal having signalcharacteristics receivable by the electromagnetically responsive controlelement and sufficient to produce a change in the distribution of theprimary material between the first active form and the second form to asecond distribution, the primary material distributed according to thesecond distribution having a second active concentration in the deliveryfluid, at step 2352; and delivering an electromagnetic delivery controlsignal to the environment containing the delivery device, theelectromagnetic delivery control signal sufficient to produce pumping ofthe delivery fluid out of the fluid-containing structure, the deliveryfluid containing the primary material at the second effectiveconcentration in the delivery fluid at step 2354.

FIG. 52 shows further variations of the method of FIG. 51. The method ofFIG. 52 include steps of delivering and electromagnetic distributioncontrol signal at step 2402 and delivering an electromagnetic deliverycontrol signal at step 2404 (e.g., as in FIG. 51), followed by a step ofgenerating an electromagnetic control signal according to a number ofoptional steps. For example, the method may include generating andtransmitting the electromagnetic control signal to the delivery devicewith a remote controller, as shown at 2406 a. Alternatively, the methodmay include generating a first electromagnetic control signal sufficientto produce a change in effective concentration of a primary material ina delivery fluid in a delivery reservoir of a delivery device; andgenerating a second electromagnetic control signal sufficient to causedelivery fluid containing primary material in solution to be releasedfrom the delivery reservoir into the environment, as shown at 2406 b.Or, the method may include generating a first electromagnetic controlsignal having frequency and magnitude sufficient to produce heating of aheating element in or near the delivery reservoir, as shown at 2406 c.Alternatively, the method may include generating a first electromagneticcontrol signal having frequency and magnitude sufficient to producecooling of a cooling element in or near the delivery reservoir, as shownat 2406 d, generating a first electromagnetic field having frequency andmagnitude sufficient to produce a conformation change of a molecularstructure, as shown at 2406 e, or generating a first electromagneticfield having frequency and magnitude sufficient to produce a volumechange of a material a molecular structure, as shown at 2406 f.

FIG. 53 shows a method of delivering a material including pumping adelivery fluid containing a primary material from a delivery reservoirof a delivery device to a downstream location at a first pumping rate atstep 2452; and controlling the effective concentration of the primarymaterial in the delivery fluid in response to a remotely transmittedelectromagnetic control signal at step 2454. In some embodiments, thefirst pumping rate may be a constant pumping rate. In some embodiment,the method may include varying the rate of delivery of the primarymaterial to the downstream location by varying the effectiveconcentration of the primary material in the delivery fluid in responseto the remotely transmitted electromagnetic control signal. In otherembodiments, the first pumping rate may be a time-varying pumping rate.In such embodiments, the method may include controlling the rate ofdelivery of the primary material to the downstream location bycontrolling both the effective concentration of the primary material inthe delivery fluid and the pumping rate. The first pumping rate ismodifiable in response to a remotely transmitted electromagnetic controlsignal, for example. The method may include controlling the effectiveconcentration of the primary material in the delivery fluid throughactivation of an electromagnetically responsive control element in thedelivery device by the remotely transmitted electromagnetic controlsignal, for example by heating of the electromagnetically responsivecontrol element, cooling of the electromagnetically responsive controlelement. In some variants of the method, activation of theelectromagnetically responsive control element may include a change inat least one dimension of the electromagnetically responsive controlelement, a change in orientation of the electromagnetically responsivecontrol element, or a change in conformation of the electromagneticallyresponsive control element.

FIG. 54 shows a method of delivering a material, including receiving afirst electromagnetic control signal with a first electromagneticallyresponsive control element in a delivery device, the delivery deviceincluding a fluid-containing structure containing a delivery fluid and aprimary material distributed between a first active form carried in thedelivery fluid and a second form, the primary material having a firsteffective concentration in the delivery fluid equal to the concentrationof the first active form in the delivery fluid at step 2502; responsiveto receipt of the first electromagnetic control signal by the firstelectromagnetically responsive control element, modifying thedistribution of the primary material between the first active form andthe second form, the primary material having a second effectiveconcentration in the delivery fluid following the modification of thedistribution of the primary material between the first active form andthe second form at step 2504; and pumping the delivery fluid containingthe primary material at the second effective concentration from thefluid-containing structure of the delivery device to a downstreamlocation at step 2506. In the method of FIG. 54, the primary materialhas a different stability in the first active form than in the secondform, a different immunogenicity in the first active form than in thesecond form, a different reactivity in the first active form than in thesecond form, or a different activity in the first active form than inthe second form.

In a variant of the method of FIG. 54, shown in FIG. 55 (with steps2552-2556 the same as steps 2502-2506), the method may include theadditional step of filtering the second form of the primary materialfrom the delivery fluid prior to pumping the delivery fluid containingthe primary material at the second effective concentration from thefluid-containing structure of the delivery device to a downstreamlocation 2558.

In the method of FIG. 54, in some embodiments the first effectiveconcentration may be lower than the second effective concentration, andsome embodiments first effective concentration may be higher than thesecond effective concentration. The method may include modifying therate of pumping of the delivery fluid to the downstream locationresponsive to receipt of a second electromagnetic control signal by asecond electromagnetically responsive control element. In someembodiments, the first electromagnetic control signal and the secondelectromagnetic control signal may be the same electromagnetic controlsignal. In other embodiments, the first electromagnetic control signalmay be different than the second electromagnetic control signal. In someembodiments, the first electromagnetically responsive control elementand the second electromagnetically responsive control element may be thesame electromagnetically responsive control element, while in otherembodiments, the first electromagnetically responsive control elementmay be a different control element than the second electromagneticallyresponsive control element. “Different” control elements may be controlelements of different types, or distinct control elements that are ofthe same type.

FIG. 56 depicts further variants on the method of FIG. 54. Steps 2602through 2606 are the same as steps 2502-2506 in FIG. 54. Steps 2608a-2608 f alternative steps for modifying the distribution of primarymaterial between the first active form and the second form. Step 2608 aincludes modifying the distribution of primary material in response toreceipt of the first electromagnetic control signal by modifying apressure within the fluid containing structure, step 2608 b includesmodifying the distribution of primary material in response to receipt ofthe first electromagnetic control signal by modifying a temperaturewithin the fluid containing structure, step 2608 c includes modifyingthe distribution of primary material in response to receipt of the firstelectromagnetic control signal by modifying a volume of the fluidcontaining structure, step 2608 d includes modifying the distribution ofprimary material in response to receipt of the first electromagneticcontrol signal by producing vibration within the fluid containingstructure, step 2608 e includes modifying the distribution of primarymaterial in response to receipt of the first electromagnetic controlsignal by producing fluid mixing within the fluid containing structure,and step 2608 f includes modifying the distribution of primary materialin response to receipt of the first electromagnetic control signal bymodifying a number of available interaction sites within the fluidcontaining structure, the available interaction sites capable ofinteracting with the primary material to produce the second form of theprimary material.

FIG. 57 illustrates a method of delivering a material, including, atstep 2652, introducing a delivery device into an environment, thedelivery device including an electromagnetically responsive controlelement, a pump, a fluid-containing structure containing a deliveryfluid and a quantity of a primary material, the primary material beingdistributed between a first active form carried in the delivery fluidand a second form according to a first distribution in which the primarymaterial has a first effective concentration in the delivery fluid equalto the concentration of the first active form in the delivery fluid, andwherein the electromagnetically responsive control element is configuredto modify the distribution of primary material between the first activeform and the second form, and a pump, the pump being activatable forpumping delivery fluid from the fluid-containing structure to adownstream location. At step 2654, the method includes a step ofdelivering an electromagnetic distribution control signal to theenvironment with signal characteristics selectively receivable by theelectromagnetically responsive control element and sufficient to producea change in the distribution of the primary material between the firstactive form and the second from to a second distribution, the primarymaterial distributed according to the second distribution having asecond effective concentration in the delivery fluid. The pump may beactivated to pump delivery fluid containing the primary material at thesecond effective concentration out of the fluid containing structure. Inone variant, the pump may be activated prior to introducing the deliverydevice into the environment. In another variant, the pump may beactivated upon introduction of the delivery device into the environment.In still another variant, the pump may be activated subsequent tointroducing the delivery device into the environment. The method asdepicted in FIG. 57 may also include delivering an electromagneticdelivery control signal having signal characteristics selectivelyreceivable by a second electromagnetically responsive control element inthe delivery device to produce the pumping of the delivery fluidcontaining the primary material at the second effective concentrationout of the fluid-containing structure. The primary material may have adifferent immunogenicity, reactivity, or stability when it is in thefirst active form than when it is in the second form.

FIG. 58 illustrates a method of controlling a delivery device, whichincludes the steps of generating an electromagnetic control signalincluding frequency components absorbable by an electromagneticallyresponsive control element of a delivery device in an environment, thedelivery device including a fluid-containing structure containing adelivery fluid and a quantity of primary material, the primary materialbeing distributed between a first active form and a second form andhaving an effective concentration in the delivery fluid equal to theconcentration of the first active form in the delivery fluid, whereinthe effective concentration of the primary material in the deliveryfluid is controllable by the electromagnetically responsive controlelement at 2702; and remotely transmitting the electromagnetic controlsignal to the delivery device with signal characteristics sufficient toactivate the electromagnetically responsive control element in thedelivery device to control the effective concentration of primarymaterial in the delivery fluid in the delivery device at 2704.

FIG. 59 illustrates an expansion of the method shown in FIG. 58, withsteps 2752 and 2754 being the same as steps 2702 and 2704, respectively,in FIG. 58, with a number of alternative steps relating to generation ofthe electromagnetic control signal. Step 2756 a includes generating theelectromagnetic control signal and transmitting the electromagneticcontrol signal to the delivery device with a remote controller. Step2756 b includes generating the electromagnetic control signal andtransmitting the electromagnetic control signal to the delivery devicewith two or more remote controllers. Step 2756 c includes generating theelectromagnetic control signal from a model-based calculation. Step 2756d includes generating the electromagnetic control signal based on astored pattern. As yet another alternative, step 2756 e includesgenerating the electromagnetic control signal based upon a feedbackcontrol scheme. A feedback control scheme may be, for example, avariable feedback control scheme.

A further expansion the method shown in FIG. 58 may include theadditional steps depicted in FIG. 60, namely receiving a feedback signalcorresponding to one or more parameters sensed from the environment at2802; and based upon the feedback signal, generating the electromagneticcontrol signal with signal characteristics expected to produce a desiredfeedback signal, at 2804. In some embodiments, receiving the feedbacksignal from the environment may include receiving signals from at leastone sensor in the environment, while in other embodiments it may includereceiving the feedback signal from the environment includes receivingsignals from two or more sensors in the environment. Receiving thefeedback signal from the environment may include receiving a measure ofthe concentration or chemical activity of a chemical within at least aportion of the environment.

In another variation of the method shown in FIG. 58, shown in FIG. 61,the method may include the additional steps of receiving a feedbacksignal from the delivery device at 2852; and based upon the feedbacksignal, generating an electromagnetic control signal having signalcharacteristics that are expected to produce a desired feedback signalat 2854. Receiving a feedback signal from the delivery device mayinclude receiving signals from at least one sensor in the deliverydevice, or alternatively, receiving a feedback signal from the deliverydevice may include receiving signals from two or more sensors in thedelivery device. For example, receiving the feedback signal from thedelivery device may include receiving a signal representing aconcentration or chemical activity of a chemical within or around thedelivery device.

Another variation of the method depicted in FIG. 58, shown in FIG. 62,may include the additional steps of receiving user input of one or morecontrol parameters at 2892; and based upon the one or more controlparameters, generating an electromagnetic control signal having signalcharacteristics expected to produce a desired effective concentration ofprimary material in the delivery fluid, as 2894. The desired effectiveconcentration of primary material in the delivery fluid may be aneffective concentration sufficient to produce a desired rate of deliveryof the first active form of the primary material to the environment bythe delivery device.

Further additions to the method depicted in FIG. 58 include steps ofactivating the electromagnetically responsive control element to produceheating or cooling, or activating the electromagnetically responsivecontrol element to produce a change in configuration of theelectromagnetically responsive control element. Steps of generating anelectromagnetic control signal and remotely transmitting theelectromagnetic control signal to the delivery device, as shown in FIG.58, may be performed according to instructions provided in the form ofsoftware, hardware or firmware. In some method embodiments, the steps ofgenerating an electromagnetic control signal and remotely transmittingthe electromagnetic control signal to the delivery device may beperformed according to instructions distributed among a plurality ofcontrollers or transmitters.

Generating the electromagnetic control signal includes generating astatic or quasi-static magnetic field, static or quasi-static electricalfield, radio-frequency electromagnetic signal, microwave electromagneticsignal, millimeter wave electromagnetic signal, optical electromagneticsignal, which may be an optical electromagnetic signal is an infraredelectromagnetic signal, or generating an ultraviolet electromagneticsignal. Generating the electromagnetic control signal may be performedunder software control.

FIG. 63 depicts a further variation of the method shown in FIG. 58, withsteps 2902 and 2904 corresponding to steps 2702 and 2704, respectively.The method includes the additional step of modifying the concentrationof the primary material within the delivery fluid in thefluid-containing structure of the delivery device by modifying the areaof an interaction region within the fluid containing structure of thedelivery device at 2906. Modifying the area of the interaction regionincludes increasing the area of the interaction region, as at 2906 a, oralternatively, decreasing the area of the interaction region, as 2906 b.In the case that the area is increased, and the interaction regionincludes interaction sites, and increasing the area of the interactionregion may include increasing the distances between interaction sites inthe interaction region, as at 2908 a, or increasing the area of theinteraction region includes increasing a number of interaction sites inthe reaction area, as at 2908 b. In the case that the area is decreased,as at 2906 b, and the interaction region includes interaction sites,decreasing the area of the interaction region may include decreasingdistances between one or more interaction sites in the interactionregion, as at 2910 a, or decreasing a number of interaction sites in thereaction area as at 2910 b.

FIG. 64 depicts a further variation of the method shown in FIG. 58, withsteps 2952 and 2954 corresponding to steps 2702 and 2704, respectively.The method further includes a further step of modifying theconcentration of the primary material in the delivery fluid by modifyinga condition at an interaction region within the fluid-containingstructure at 2956. Modifying a condition at the interaction region mayinclude heating or cooling at least a portion of the interaction region,as shown at 2958 a, modifying the osmolality or the pH of at least aportion of the interaction region, at 2958 b, modifying the surfacecharge of at least a portion of the interaction region, at 2958 c, ormodifying the surface energy of at least a portion of the interactionregion, as 1958 d.

In another variation, shown in FIG. 65, the method includes a furtherstep of modifying a condition at the interaction region by modifying acondition within the fluid-containing structure, as indicated at step3006 (steps 3002 and 3004 correspond to steps 2702 and 2704 in FIG. 58).Modifying a condition within the fluid-containing structure may includemodifying the volume of the fluid-containing structure, as shown at 3008a, heating or cooling at least a portion of the fluid-containingstructure, as shown at 3008 b, or modifying the osmolality or the pHwithin at least a portion of the fluid-containing structure, as shown at3008 c.

Software may be used in performing various of the methods as describedherein. Such software includes software for controlling delivery of amaterial from a delivery device, including instructions for generatingan electromagnetic control signal including frequency componentsabsorbable by an electromagnetically responsive control element of adelivery device in an environment, the delivery device including afluid-containing structure containing a delivery fluid and a quantity ofprimary material, the primary material being distributed between a firstactive form and a second form and having an effective concentration inthe delivery fluid equal to the concentration of the first active formin the delivery fluid, wherein the effective concentration of theprimary material in the delivery fluid is controllable by theelectromagnetically responsive control element; and instructions forcontrolling the transmission of the electromagnetic control signal tothe delivery device with signal characteristics sufficient to activatethe electromagnetically responsive control element in the deliverydevice to control the effective concentration of primary material in thedelivery fluid in the delivery device.

The software may include instructions for generating the electromagneticcontrol signal include instructions for calculating the electromagneticcontrol signal based on a model. The instructions for generating theelectromagnetic control signal may include instructions for generatingthe electromagnetic control signal based on a pattern stored in a datastorage location, or instructions for generating the electromagneticcontrol signal based upon a feedback control algorithm. For example, theinstructions for generating the electromagnetic control signal mayinclude instructions for generating the electromagnetic control signalbased upon a variable feedback control algorithm. The software mayinclude instructions for receiving a feedback signal corresponding toone or more parameters sensed from the environment; and instructions forgenerating the electromagnetic control signal based at least in partupon the received feedback signal, the electromagnetic control signalhaving signal characteristics expected to produce a desired feedbacksignal. Some embodiments of the software may include instructions forreceiving a feedback signal from the delivery device; and instructionsfor generating the electromagnetic control signal based at least in parton the received feedback signal, the electromagnetic control signalhaving frequency composition and amplitude expected to produce a desiredfeedback signal. In some embodiments, the software may includeinstructions for receiving user input of one or more control parameters;and instructions for generating the electromagnetic control signal basedat least in part upon the one or more control parameters. In someembodiments, the software may include instructions for performingencryption of the electromagnetic control signal. Instruction may beincluded for performing an authentication procedure between a remotecontroller transmitting the electromagnetic control signal and adelivery device including the electromagnetically responsive controlelement intended to be activated by the electromagnetic control signal.At least a portion of the instructions generating the electromagneticcontrol signal and the instruction for controlling the transmission ofthe electromagnetic control signal are executable in distributed fashionon a plurality of microprocessors. Some embodiments of the software mayinclude channel allocation instructions configured to control theallocation of control signal transmission channels for transmission of aplurality of control signals to a corresponding plurality of deliverydevices.

With regard to the hardware and/or software used in the control ofdevices and systems according to the present embodiments, andparticularly to the sensing, analysis, and control aspects of suchsystems, those having skill in the art will recognize that the state ofthe art has progressed to the point where there is little distinctionleft between hardware and software implementations of aspects ofsystems; the use of hardware or software is generally (but not always,in that in certain contexts the choice between hardware and software canbecome significant) a design choice representing cost vs. efficiency orimplementation convenience tradeoffs. Those having skill in the art willappreciate that there are various vehicles by which processes and/orsystems described herein can be effected (e.g., hardware, software,and/or firmware), and that the preferred vehicle will vary with thecontext in which the processes are deployed. For example, if animplementer determines that speed and accuracy are paramount, theimplementer may opt for a hardware and/or firmware vehicle;alternatively, if flexibility is paramount, the implementer may opt fora solely software implementation; or, yet again alternatively, theimplementer may opt for some combination of hardware, software, and/orfirmware. Hence, there are several possible vehicles by which theprocesses described herein may be effected, none of which is inherentlysuperior to the other in that any vehicle to be utilized is a choicedependent upon the context in which the vehicle will be deployed and thespecific concerns (e.g., speed, flexibility, or predictability) of theimplementer, any of which may vary.

The foregoing detailed description has set forth various embodiments ofthe devices and related processes or methods via the use of blockdiagrams, flowcharts, and/or examples. Insofar as such block diagrams,flowcharts, and/or examples contain one or more functions and/oroperations, it will be implicitly understood by those with skill in theart that each function and/or operation within such block diagrams,flowcharts, or examples can be implemented, individually and/orcollectively, by a wide range of hardware, software, firmware, orvirtually any combination thereof. In one embodiment, several portionsof the subject matter subject matter described herein may be implementedvia Application Specific Integrated Circuits (ASICs), Field ProgrammableGate Arrays (FPGAs), digital signal processors (DSPs), or otherintegrated formats. However, those skilled in the art will recognizethat some aspects of the embodiments disclosed herein, in whole or inpart, can be equivalently implemented in standard integrated circuits,as one or more computer programs running on one or more computers (e.g.,as one or more programs running on one or more computer systems), as oneor more programs running on one or more processors (e.g., as one or moreprograms running on one or more microprocessors), as firmware, or asvirtually any combination thereof, and that designing the circuitryand/or writing the code for the software and/or firmware would be wellwithin the capabilities of one of skill in the art in light of thisdisclosure. In addition, those skilled in the art will appreciate thatcertain mechanisms of the subject matter described herein are capable ofbeing distributed as a program product in a variety of forms, and thatan illustrative embodiment of the subject matter described hereinapplies equally regardless of the particular type of signal bearingmedia used to actually carry out the distribution. Examples of a signalbearing media include, but are not limited to, the following: recordabletype media such as floppy disks, hard disk drives, CD ROMs, digitaltape, and computer memory; and transmission type media such as digitaland analog communication links using TDM or IP based communication links(e.g., links carrying packetized data).

In a general sense, those skilled in the art will recognize that thevarious aspects described herein which can be implemented, individuallyand/or collectively, by a wide range of hardware, software, firmware, orany combination thereof can be viewed as being composed of various typesof “electrical circuitry.” Consequently, as used herein “electricalcircuitry” includes, but is not limited to, electrical circuitry havingat least one discrete electrical circuit, electrical circuitry having atleast one integrated circuit, electrical circuitry having at least oneapplication specific integrated circuit, electrical circuitry forming ageneral purpose computing device configured by a computer program (e.g.,a general purpose computer configured by a computer program which atleast partially carries out processes and/or devices described herein,or a microprocessor configured by a computer program which at leastpartially carries out processes and/or devices described herein),electrical circuitry forming a memory device (e.g., forms of randomaccess memory), and/or electrical circuitry forming a communicationsdevice (e.g., a modem, communications switch, or optical-electricalequipment).

Those skilled in the art will recognize that it is common within the artto describe devices for detection or sensing, signal processing, anddevice control in the fashion set forth herein, and thereafter usestandard engineering practices to integrate such described devicesand/or processes into fluid handling and/or delivery systems asexemplified herein. That is, at least a portion of the devices and/orprocesses described herein can be integrated into a fluid handlingand/or delivery system via a reasonable amount of experimentation.

Those having skill in the art will recognize that systems as describedherein may include one or more of a memory such as volatile andnon-volatile memory, processors such as microprocessors and digitalsignal processors, computational-supporting or—associated entities suchas operating systems, user interfaces, drivers, sensors, actuators,applications programs, one or more interaction devices, such as dataports, control systems including feedback loops and control implementingactuators (e.g., devices for sensing osmolality, pH, pressure,temperature, or chemical concentration, signal generators for generatingelectromagnetic control signals). A system may be implemented utilizingany suitable available components, combined with standard engineeringpractices.

The foregoing-described aspects depict different components containedwithin, or connected with, different other components. It is to beunderstood that such depicted architectures are merely exemplary, andthat in fact many other architectures can be implemented which achievethe same functionality. In a conceptual sense, any arrangement ofcomponents to achieve the same functionality is effectively “associated”such that the desired functionality is achieved. Hence, any twocomponents herein combined to achieve a particular functionality can beseen as “associated with” each other such that the desired functionalityis achieved, irrespective of architectures or intermediate components.Likewise, any two components so associated can also be viewed as being“operably connected”, or “operably coupled”, to each other to achievethe desired functionality.

While particular aspects of the present subject matter described hereinhave been shown and described, it will be obvious to those skilled inthe art that, based upon the teachings herein, changes and modificationsmay be made without departing from this subject matter described hereinand its broader aspects and, therefore, the appended claims are toencompass within their scope all such changes and modifications as arewithin the true spirit and scope of this subject matter describedherein. Furthermore, it is to be understood that the invention isdefined by the appended claims. It will be understood by those withinthe art that, in general, terms used herein, and especially in theappended claims (e.g., bodies of the appended claims) are generallyintended as “open” terms (e.g., the term “including” should beinterpreted as “including but not limited to,” the term “having” shouldbe interpreted as “having at least,” the term “includes” should beinterpreted as “includes but is not limited to,” etc.). It will befurther understood by those within the art that if a specific number ofan introduced claim recitation is intended, such an intent will beexplicitly recited in the claim, and in the absence of such recitationno such intent is present. For example, as an aid to understanding, thefollowing appended claims may contain usage of the introductory phrases“at least one” and “one or more” to introduce claim recitations.However, the use of such phrases should NOT be construed to imply thatthe introduction of a claim recitation by the indefinite articles “a” or“an” limits any particular claim containing such introduced claimrecitation to inventions containing only one such recitation, even whenthe same claim includes the introductory phrases “one or more” or “atleast one” and indefinite articles such as “a” or “an” (e.g., “a” and/or“an” should typically be interpreted to mean “at least one” and/or “oneor more”); the same holds true for the use of definite articles used tointroduce claim recitations. In addition, even if a specific number ofan introduced claim recitation is explicitly recited, those skilled inthe art will recognize that such recitation should typically beinterpreted to mean at least the recited number (e.g., the barerecitation of “two recitations,” without other modifiers, typicallymeans at least two recitations, or two or more recitations).Furthermore, in those instances where a convention analogous to “atleast one of A, B, and C, etc.” is used, in general such a constructionis intended in the sense of one having skill in the art would understandthe convention (e.g., “a system having at least one of A, B, and C”would include but not be limited to systems that have A alone, B alone,C alone, A and B together, A and C together, B and C together, and/or A,B, and C together). In those instances where a convention analogous to“at least one of A, B, or C, etc.” is used, in general such aconstruction is intended in the sense of one having skill in the artwould understand the convention (e.g., “a system having at least one ofA, B, or C” would include but not be limited to systems that have Aalone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together).

Although the methods, devices, systems and approaches herein have beendescribed with reference to certain preferred embodiments, otherembodiments are possible. As illustrated by the foregoing examples,various choices of remote controller, system configuration and fluidhandling/delivery device may be within the scope of the invention. Ashas been discussed, the choice of system configuration may depend on theintended application of the system, the environment in which the systemis used, cost, personal preference or other factors. System design,manufacture, and control processes may be modified to take into accountchoices of use environment and intended application, and suchmodifications, as known to those of skill in the arts of device designand construction, may fall within the scope of the invention. Therefore,the full spirit or scope of the invention is defined by the appendedclaims and is not to be limited to the specific embodiments describedherein.

While various aspects and embodiments have been disclosed herein, otheraspects and embodiments will be apparent to those skilled in the art. Itis intended that the various aspects and embodiments disclosed hereinare for purposes of illustration and are not intended to be limiting,with the true scope and spirit being indicated by the following claims.

1. A method of delivering a fluid to an environment, comprising:generating a first electromagnetic control signal absorbable by anelectromagnetically responsive control element to produce a change ineffective concentration of a primary material in a delivery fluid in adelivery reservoir of a delivery device from a first effectiveconcentration to a second effective concentration by modifying adistribution of primary material between a first active form and asecond form within the delivery reservoir; and generating a secondelectromagnetic control signal sufficient to cause delivery fluidcontaining primary material in solution at said second effectiveconcentration to be released from the delivery reservoir into theenvironment.
 2. The method of claim 1, including generating the secondelectromagnetic control signal based at least in part according to apre-determined activation pattern.
 3. The method of claim 1, includinggenerating the second electromagnetic control signal according to amodel-based calculation.
 4. The method of claim 1, including receiving afeedback signal from the environment and producing the secondelectromagnetic control signal based at least in part upon the feedbacksignal received from the environment.
 5. The method of claim 1,including receiving a feedback signal from the delivery device andproducing the second electromagnetic control signal based at least inpart upon the feedback signal from the delivery device.
 6. The method ofclaim 5, wherein receiving a feedback signal from the delivery deviceincludes receiving a feedback signal corresponding to a concentration orchemical activity of a chemical within or around the delivery device. 7.The method of claim 5, wherein receiving a feedback signal from thedelivery device includes receiving a feedback signal corresponding tothe pumping rate of the delivery device.
 8. The method of claim 1,wherein generating the first electromagnetic control signal includesgenerating an electromagnetic control signal sufficient to produce achange in effective concentration of a primary material in a deliveryfluid in a delivery reservoir in each of a plurality of deliverydevices.
 9. The method of claim 8, including receiving a plurality ofsignals from the plurality of delivery devices and generating at leastone of the first electromagnetic control signal and the secondelectromagnetic control signal based upon the plurality of signals. 10.The method of claim 8, including: allocating usage of a plurality oftransmission channels for transmission of the first electromagneticcontrol signal to selected delivery devices of the plurality of deliverydevices; and transmitting the first electromagnetic control signal tothe selected delivery devices of the plurality of delivery devices. 11.The method of claim 1, wherein at least one of generating the firstelectromagnetic control signal and generating the second electromagneticcontrol signal includes encrypting one or more control signalcomponents.
 12. The method of claim 1, including: generating atransmittable RFID interrogation signal; transmitting the transmittableRFID interrogation signal; receiving a returned RFID interrogationsignal from an RFID in a delivery device; detecting the presence of aselected RFID from a returned RFID interrogation signal; and upondetection of the presence of the selected RFID, generating andtransmitting a control signal configured for receipt by the deliverydevice including the selected RFID.
 13. The method of claim 1, includinggenerating at least one of the first electromagnetic control signal andthe second electromagnetic control signal with an electromagnet orelectrically-polarizable element.
 14. The method of claim 1, includinggenerating at least one of the first electromagnetic control signal andthe second electromagnetic control signal with at least one permanentmagnet or electret.
 15. The method of claim 1, wherein at least one ofgenerating the first electromagnetic control signal and generating thesecond electromagnetic control signal includes generating a signalselected from the group consisting of a radio-frequency signal, amicrowave signal, infrared signal, a millimeter wave signal, an opticalsignal, and an ultraviolet signal.
 16. The method of claim 1, wherein atleast one of generating the first electromagnetic control signal andgenerating the second electromagnetic control signal includes generatinga rotating electromagnetic control signal.